FDA 510(k) Applications for Medical Device:
Enzyme Immunoassay, Opiates
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K013314 | ABBOTT LABORATORIES |
1920 HURD DR. | IRVING | TX | 75038 |
| K060466 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K013380 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K040274 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K011353 | ACON LABORATORIES, INC. |
4104 SORRENTO VALLY BLVD. | SAN DIEGO | CA | 92121 |
| K043507 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K033047 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K053037 | ACRO BIOTECH LLC. |
9500 7TH STREET UNIT M | RANCHO CUCAMONGA | CA | 91730-9094 |
| K991883 | ADVANTAGE DIAGNOSTICS CORP. |
3573 WESTWIND BLVD. | SANTA ROSA | CA | 95403 |
| K201494 | Advin Biotech, Inc. |
10237 Flanders Ct | San Diego | CA | 92121 |
| K182123 | Advin Biotech, Inc. |
10340 Camino Santa Fe, Suite G | San Diego | CA | 92121 |
| K060527 | ALFA SCIENTIFIC DESIGNS, INC. |
13200 GREGG ST. | POWAY | CA | 92064 |
| K100051 | ALFA SCIENTIFIC DESIGNS, INC. |
13200 GREGG ST. | POWAY | CA | 92064 |
| K063545 | ALFA SCIENTIFIC DESIGNS, INC. |
13200 GREGG ST. | POWAY | CA | 92064 |
| K023047 | AMEDICA BIOTECH, INC. |
28301 INDUSTRIAL BLVD SUITE K | HAYWARD | CA | 94545 |
| K012483 | AMEDITECH, INC. |
10340 CAMINO SANTA FE | SAN DIEGO | CA | 92121 |
| K063015 | AMEDITECH, INC. |
10340 CAMINO SANTA FE | SAN DIEGO | CA | 92121 |
| K993151 | AMERICAN BIO MEDICA CORP. |
1001 G STREET, NW | WASHINGTON | DC | 20001 |
| K990820 | AMERICAN BIO MEDICA CORP. |
1001 G STREET, NW | WASHINGTON | DC | 20001 |
| K060760 | AMERICAN BIO MEDICA CORP. |
9110 RED BRANCH ROAD | COLUMBIA | MD | 21045 |
| K014101 | AMERICAN BIO MEDICA CORP. |
9110 RED BRANCH RD. | COLUMBIA | MD | 21045 |
| K983190 | AMERITEK, INC. |
7030 35TH AVE., N.E. | SEATTLE | WA | 98115 |
| K180427 | ARK Diagnostics, Inc. |
48089 Fremont Boulevard | Fremont | CA | 94538 |
| K200197 | ARK Diagnostics, Inc. |
48089 Fremont Boulevard | Fremont | CA | 94538 |
| K231752 | ARK Diagnostics, Inc. |
48089 Fremont Boulevard | Fremont | CA | 94538 |
| K182280 | ARK Diagnostics, Inc. |
48089 Fremont Boulevard | Fremont | CA | 94538 |
| K201630 | Assure Tech (Hangzhou) Co., Ltd. |
2nd-5th Floor, Building 4, No. 1418-50, Moganshan Road, | Hangzhou | 310011 | |
| K031002 | BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110 | BREA | CA | 92822 |
| K984152 | BECKMAN COULTER, INC. |
200 S. KRAEMER BLVD.,M/S W-104 | BREA | CA | 92822-8000 |
| K971596 | BEHRING DIAGNOSTICS, INC. |
3403 YERBA BUENA RD. | SAN JOSE | CA | 95161-9013 |
| K971361 | BIONIKE LABORATORIES, INC. |
1015 GRANDVIEW DR. | SOUTH SAN FRANCISCO | CA | 94080-4910 |
| K133642 | BIOPHOR DIAGNOSTICS, INC. |
1201 DOUGLAS AVE | REDWOOD CITY | CA | 94063 |
| K962795 | BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. | CONCORD | CA | 94524 |
| K954498 | BOEHRINGER MANNHEIM CORP. |
1700 ROCKVILLE PIKE | ROCKVILLE | MD | 20852 |
| K030113 | BRANAN MEDICAL CORP. |
10015 MUIRLANDS RD., SUITE E | IRVINE | CA | 92618 |
| K002268 | BRANAN MEDICAL CORPORATION |
10015 MUIRLANDS RD. SUITE E | IRVINE | CA | 92618 |
| K082508 | BRANAN MEDICAL CORPORATION |
140 TECHNOLOGY DRIVE | IRVINE | CA | 92618 |
| K142396 | Chemtron Biotech, Inc. |
9245 Brown Deer Road | San Diego | CA | 92121 |
| K143599 | Chemtron Biotech, Inc. |
9245 Brown Deer Road | San Diego | CA | 92121 |
| K153192 | Chemtron Biotech, Inc. |
9245 Brown Deer Road | San Diego | CA | 92121 |
| K232736 | Chemtron Biotech, Inc. |
9245 Brown Deer Road, Suite B | San Diego | CA | 92121 |
| K153050 | Co-Innovation Biotech Co., Ltd |
No. 13, Yanyuan Road, Tianhe District, | Guangzhou | ||
| K140748 | CO-INNOVATION BIOTECH CO.,LTD. |
No.13, Yanyuan Road, Tianhe District, | Guangzhou | 510507 | |
| K231904 | Co-Innovation Biotech Co.,Ltd. |
No.9 Baihe 3 Street, | Guangzhou | 510530 | |
| K020920 | COZART BIOSCIENCE LTD. |
45 MILTON PARK | OXFORDSHIRE OX14 4RU | OX14 4RU | |
| K000464 | DADE BEHRING, INC. |
RT. 896, GLASCOW BLDG. 500 | NEWARK | DE | 19714 |
| K003209 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K962323 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K972405 | DRIAL CONSULTANTS, INC. |
1420 LOS ANGELES AVE. STE 201 | SIMI VALLEY | CA | 93065 |
| K972571 | DRIAL CONSULTANTS, INC. |
1420 LOS ANGELES AVE. STE 201 | SIMI VALLEY | CA | 93065 |
| K000273 | DRUG DETECTION DEVICES, LTD. |
6820 MEADOWRIDGE COURT | ALPHARETTA | GA | 30005 |
| K232659 | Guangzhou Decheng Biotechnology Co., Ltd. |
Room 107/218/212/405, Building 2, No. 68, | Guangzhou | 510000 | |
| K240698 | Guangzhou Decheng Biotechnology Co., Ltd. |
Floor 3/4/5/7, Building A1, No.12, Nanyun 1st Road | Guangzhou | 510663 | |
| K130055 | Guangzhou Wondfo Biotech Co., Ltd. |
504 EAST DIAMOND AVE. | GAITHERSBURG | MD | 20878 |
| K150179 | GUANGZHOU WONDFO BIOTECH CO., LTD. |
WONDFO SCIENTECH PARK, SOUTH | GUANGZHOU | 510641 | |
| K140089 | Guangzhou Wondfo Biotech Co., Ltd. |
504 EAST DIAMOND AVE. | GAITHERSBURG | MD | 20878 |
| K113624 | Guangzhou Wondfo Biotech Co., Ltd. |
504 EAST DIAMOND AVE | GAITHERSBURG | MD | 20878 |
| K151478 | GUANGZHOU WONDFO BIOTECH CO., LTD. |
WONDFO SCIENTECH PARK, SOUTH CHINA UNIV. OF TECHNOLOGY | GUANGZHOU | 510641 | |
| K112310 | Guangzhou Wondfo Biotech Co., Ltd. |
504 EAST DIAMOND AVE. | GAITHERSBURG | MD | 20878 |
| K093175 | Guangzhou Wondfo Biotech Co., Ltd. |
1 CONGRESSIONAL DRIVE | GREENVILLE | DE | 19807 |
| K130665 | Guangzhou Wondfo Biotech Co., Ltd. |
504 EAST DIAMOND AVE. | GAITHERSBURG | MD | 20878 |
| K231698 | Hangzhou AllTest Biotech Co., Ltd. |
#550, Yinhai Street | Hangzhou | 310018 | |
| K232597 | Hangzhou Laihe Biotech Co., Ltd. |
Room 401-406, F1-3, Building 1, No.425 Miaohouwang Road | Hangzhou | 310051 | |
| K143187 | Healgen Scientific LLC |
5213 Maple St | Bellaire | TX | 77401 |
| K142280 | HEALGEN SCIENTIFIC LLC |
5213 MAPLE STREET | BELLAIRE | TX | 77401 |
| K150275 | Immunalysis Corporation |
829 TOWNE CENTER DR. | POMONA | CA | 91767 |
| K141406 | Immunalysis Corporation |
829 TOWNE CENTER DR. | POMONA | CA | 91767 |
| K051626 | Immunalysis Corporation |
829 TOWNE CENTER DR. | POMONA | CA | 91767 |
| K143502 | IMMUNALYSIS CORPORATION |
829 TOWNE CENTER DR | POMONA | CA | 91767 |
| K131168 | Immunalysis Corporation |
829 TOWNE CENTER DR. | POMONA | CA | 91767 |
| K161216 | IMMUNALYSIS CORPORATION |
829 TOWNE CENTER DRIVE | POMONA | CA | 91767 |
| K141803 | Immunalysis Corporation |
829 TOWNE CENTER DR. | POMONA | CA | 91767 |
| K203564 | Immunalysis Corporation |
829 Towne Center Drive | Pomona | CA | 91767 |
| K172416 | Infrared Laboratory Systems, LLC (dba Synermed) |
17408 Tiller Court, Suite 1900 | Westfield | IN | 40674 |
| K041747 | LIFEPOINT,INC |
1205 SOUTH DUPONT ST. | ONTARIO | CA | 91761 |
| K041746 | LIFEPOINT,INC |
1205 SOUTH DUPONT ST. | ONTARIO | CA | 91761 |
| K101195 | Lin-Zhi International, Inc. |
670 ALMANOR AVE | SUNNYVALE | CA | 94085 |
| K090844 | Lin-Zhi International, Inc. |
687 NORTH PASTORIA AVE. | SUNNYVALE | CA | 94085-2917 |
| K081008 | Lin-Zhi International, Inc. |
687 NORTH PASTORIA AVE. | SUNNYVALE | CA | 94085-2917 |
| K181159 | Lin-Zhi International, Inc. |
2945 Oakmead Village Court | Santa Clara | CA | 95051 |
| K201938 | Lin-Zhi International, Inc. |
2945 Oakmead Village Court | Santa Clara | CA | 95051 |
| K251634 | Lin-Zhi International, Inc. |
2945 Oakmead Village Court | Santa Clara | CA | 95051 |
| K141055 | Lin-Zhi International, Inc. |
670 ALMANOR AVE | SUNNYVALE | CA | 94085 |
| K120761 | Lin-Zhi International, Inc. |
670 ALMANOR AVE | SUNNYVALE | CA | 94085 |
| K141205 | Lin-Zhi International, Inc. |
670 ALMANOR AVE | SUNNYVALE | CA | 94085 |
| K120763 | Lin-Zhi International, Inc. |
670 ALMANOR AVE | SUNNYVALE | CA | 94085 |
| K202007 | Lin-Zhi International, Inc. |
2945 Oakmead Village Court | Santa Clara | CA | 95051 |
| K201223 | Lin-Zhi International, Inc. |
2945 Oakmead Village Court | Santa Clara | CA | 95051 |
| K110298 | Lin-Zhi International, Inc. |
670 ALmanor Avenue | Sunnyvale | CA | 94085 |
| K020368 | Lin-Zhi International, Inc. |
2391 ZANKER RD., SUITE 340 | SAN JOSE | CA | 95131-1124 |
| K050733 | Lin-Zhi International, Inc. |
687 NORTH PASTORIA AVE. | SUNNYVALE | CA | 94085-2917 |
| K203527 | lmmunalysis Corporation |
829 Towne Center Drive | Pomona | CA | 91767 |
| K100951 | MEDTOX DIAGNOSTICS, INC. |
1238 ANTHONY RD. | BURLINGTON | NC | 27215 |
| K060351 | MEDTOX DIAGNOSTICS, INC. |
1238 ANTHONY RD. | BURLINGTON | NC | 27215 |
| K091454 | MEDTOX DIAGNOSTICS, INC. |
1238 ANTHONY RD. | BURLINGTON | NC | 27215 |
| K100023 | MEDTOX DIAGNOSTICS, INC. |
1238 ANTHONY RD. | BURLINGTON | NC | 27215 |
| K992111 | MEDTOX DIAGNOSTICS, INC. |
1238 ANTHONY RD. | BURLINGTON | NC | 27215 |
| K031032 | MEDTOX DIAGNOSTICS, INC. |
1238 ANTHONY RD. | BURLINGTON | NC | 27215 |
| K973761 | MICRODIAGNOSTICS, INC. |
28062 FORBES ROAD, SUITE B | LAGUNA NIGUEL | CA | 92677 |
| K040316 | MICROGENICS CORP. |
46360 FREMONT BLVD. | FREMONT | CA | 94538 |
| K001178 | MICROGENICS CORP. |
46360 FREMONT BLVD. | FREMONT | CA | 94538 |
| K011150 | MICROGENICS CORP. |
46360 FREMONT BLVD. | FREMONT | CA | 94538 |
| K101754 | MICROGENICS CORP. |
46360 FREMONT BLVD | FREMONT | CA | 94538 |
| K163101 | MICROGENICS CORPORATION |
46500 KATO ROAD | FREMONT | CA | 94538 |
| K173183 | Microgenics Corporation |
46500 Kato Road | Fremont | CA | 94538 |
| K192943 | Microgenics Corporation |
46500 Kato Road | Fremont | CA | 94538 |
| K231007 | Microgenics Corporation |
46500 Kato Road | Fremont | CA | 94538 |
| K173195 | Microgenics Corporation |
46500 Kato Road | Fremont | CA | 94538 |
| K150502 | Microgenics Corporation |
46500 Kato Road | Fremont | CA | 94538 |
| K051958 | MP BIOMEDICALS, LLC. |
9418 LASAINE AVE. | NORTHRIDGE | CA | 91325 |
| K063699 | NOVX SYSTEMS INC. |
16809 BRIARDALE ROAD | ROCKVILLE | MD | 20853 |
| K103161 | OMEGA LABORATORIES, INC. |
400 NORTH CLEVELAND | MOGADORE | OH | 44260 |
| K140671 | OMEGA LABORATORIES, INC. |
400 NORTH CLEVELAND | MOGADORE | OH | 44260 |
| K981341 | ORASURE TECHNOLOGIES, INC. |
1745 EATON AVE. | BETHLEHEM | PA | 18018-1799 |
| K020371 | ORASURE TECHNOLOGIES, INC. |
1745 EATON AVE. | BETHLEHEM | PA | 18018-1799 |
| K062460 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K994234 | PHAMATECH |
9265 ACTIVITY RD., #112-113 | SAN DIEGO | CA | 92126 |
| K972619 | PHAMATECH |
9265 ACTIVITY RD. | SANDIEGO | CA | 92126 |
| K993165 | PHAMATECH |
9265 ACTIVITY RD., #112-113 | SAN DIEGO | CA | 92126 |
| K013408 | PHAMATECH INC. |
9530 PADGETT ST., #101 | SAN DIEGO | CA | 92126 |
| K013407 | PHAMATECH INC. |
9530 PADGETT ST., #101-106 | SAN DIEGO | CA | 92126 |
| K043051 | PHAMATECH INC. |
10151 BARNES CANYON RD | SAN DIEGO | CA | 92121 |
| K992422 | PRINCETON BIOMEDITECH CORP. |
4242 U.S. RT. 1 | MONMOUTH JUNCTION | NJ | 08852-1905 |
| K981771 | PRINCETON BIOMEDITECH CORP. |
P.O. BOX 7139 | PRINCETON | NJ | 08543-7139 |
| K130650 | PRINCETON BIOMEDITECH CORP. |
4242 U.S. HIGHWAY 1 | MONMOUTH JUNCTION | NJ | 08852-1905 |
| K000851 | PSYCHEMEDICS CORP. |
1280 MASSACHUSETTS AVE. | CAMBRIDGE | MA | 02138 |
| K123799 | PSYCHEMEDICS CORP. |
5832 UPLANDER WAY | CULVER CITY | CA | 90230 |
| K111926 | PSYCHEMEDICS CORP. |
5832 UPLANDER WAY | CULVER CITY | CA | 90230 |
| K201326 | Psychemedics Corporation |
5832 Uplander Way | Culver City | CA | 90230 |
| K182103 | Psychemedics Corporation |
5832 Uplander Way | Culver City | CA | 90230 |
| K042725 | QUEST DIAGNOSTICS, INC. |
4230 BURNHAM AVE. | LAS VEGAS | NV | 89119-5410 |
| K221550 | Randox Laboratories Limited |
55 Diamond Road | Crumlin | BT29 4QY | |
| K220451 | Randox Laboratories Limited |
55 Diamond Road | Crumlin | BT29 4Qy | |
| K113747 | RANDOX LABORATORIES LIMITED |
55 DIAMOND ROAD | CRUMLIN | BT29 4QY | |
| K041144 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K020716 | RAPID DIAGNOSTICS, INC. |
1429 ROLLINS RD. | BURLINGAME | CA | 94010 |
| K974840 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
BRANCHBURG TOWNSHIP | SOMERVILLE | NJ | 08876-3771 |
| K093867 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K013482 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K992890 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K232228 | Shanghai Accurature Diagnostics Co., Ltd. |
Building 1,No.168 Banqiao East Road,Shanyang Town | Shanghai | ||
| K230238 | Shenzhen Bioeasy Biotechnology Co.,Ltd. |
No.2-1,Liuxian 1st Road,Xin'an Sub-District | Shenzhen | 518101 | |
| K220046 | Shenzhen Superbio Technology Co.,Ltd. |
Building B, Xinzheng, 71 Area, | Shenzhen | 518101 | |
| K172910 | Siemens Healthcare Diagnostics Inc. |
P.O. Box 6101, M/S 514 | Newark | DE | 19714-6101 |
| K102779 | Siemens Healthcare Diagnostics Inc. |
P.O. BOX 6101 | NEWARK | DE | 19714 |
| K150606 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
P.O. BOX 6101, M/S 514 | NEWARK | DE | 19714-6101 |
| K221605 | Siemens Healthcare Diagnostics, Inc. |
500 GBC Dr. P.O. Box 6101, Mailstop 514 | Newark | DE | 19714 |
| K993491 | SYNTRON BIORESEARCH, INC. |
1420 LOS ANGELES AVE. | SIMI VALLEY | CA | 93065 |
| K993490 | SYNTRON BIORESEARCH, INC. |
1420 LOS ANGELES AVE. | SIMI VALLEY | CA | 93065 |
| K984232 | SYVA CO. |
3403 YERBA BUENA RD. | SAN JOSE | CA | 95135-1500 |
| K011289 | SYVA CO., DADE BEHRING, INC. |
P.O. BOX 49013 | SAN JOSE | CA | 95135 |
| K042990 | Tianjin New Bay Bioresearch Co., Ltd. |
3108 AVENIDA OLMEDA | CARLSBAD | CA | 92009 |
| K122064 | Tianjin New Bay Bioresearch Co., Ltd. |
4455 Murphy Canyon Rd | San Diego | CA | 92123 |
| K130275 | Tianjin New Bay Bioresearch Co., Ltd. |
4455 Murphy Canyon Rd | San Diego | CA | 92123 |
| K052520 | Tianjin New Bay Bioresearch Co., Ltd. |
3108 AVENIDA OLMEDA | CARLSBAD | CA | 92009 |
| K042988 | Tianjin New Bay Bioresearch Co., Ltd. |
3108 AVENIDA OLMEDA | CARLSBAD | CA | 92009 |
| K091612 | UCP BIOSCIENCES, INC. |
1445 KOLL CIRCLE, STE. 111 | SAN JOSE | CA | 95112 |
| K973153 | UNITED BIOTECH, INC. |
110 PIONEER WAY, #C | MOUNTAIN VIEW | CA | 94041-1517 |
| K973156 | UNITED BIOTECH, INC. |
110 PIONEER WAY, #C | MOUNTAIN VIEW | CA | 94041-1517 |
| K973155 | UNITED BIOTECH, INC. |
110 PIONEER WAY, #C | MOUNTAIN VIEW | CA | 94041-1517 |
| K240124 | VivaChek Biotech (Hangzhou) Co., Ltd |
Level 2, Block 2, 146 East Chaofeng Rd. | Hangzhou | 311100 | |
| K152551 | W.H.P.M., INC. |
5358 IRWINDALE AVE. | IRWINDALE | CA | 91706 |
| K222955 | Xenta Biomedical Science Co., Ltd. |
Building C5, 9th Floor, Rm 901, No. 11 Kaiyuan Avenue, | Guangzhou | 510535 |
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