FDA 510(k) Applications for Medical Device:
Enzyme Immunoassay, Amphetamine
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K020313 | ACON LABORATORIES CO. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K041822 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K011673 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K041685 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K031759 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K041743 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K053032 | ACRO BIOTECH LLC. |
9500 7TH STREET UNIT M | RANCHO CUCAMONGA | CA | 91730-9094 |
| K023712 | ADVANTAGE DIAGNOSTICS CORP |
764 SAN ALESO AVE. | SUNNYVALE | CA | 94085 |
| K122809 | ADVIN BIOTECH |
6861 NANCY RIDGE DR. | SAN DIEGO | CA | 92121 |
| K173303 | Alfa Scientific Designs, Inc |
13200 Gregg Street | Poway | CA | 92064 |
| K994395 | ALFA SCIENTIFIC DESIGNS, INC. |
11494 SORRENTO VALLEY RD., | SAN DIEGO | CA | 92121 |
| K994399 | ALFA SCIENTIFIC DESIGNS, INC. |
11494 SORRENTO VALLEY RD., | SAN DIEGO | CA | 92121 |
| K131645 | ALFA SCIENTIFIC DESIGNS, INC. |
13200 GREGG ST. | POWAY | CA | 92064 |
| K022564 | ALFA SCIENTIFIC DESIGNS, INC. |
12330 STOWE DR. | POWAY | CA | 92064 |
| K152122 | ALFA SCIENTIFIC DESIGNS, INC. |
13200 GREGG ST. | POWAY | CA | 92064 |
| K023104 | AMEDICA BIOTECH, INC. |
28301 INDUSTRIAL BLVD SUITE K | HAYWARD | CA | 94545 |
| K063379 | AMEDICA BIOTECH, INC. |
28301 INDUSTRIAL BLVD SUITE K | HAYWARD | CA | 94545 |
| K053175 | AMEDITECH, INC. |
10340 CAMINO SANTA FE, SUITE F | SAN DIEGO | CA | 92121 |
| K040092 | AMEDITECH, INC. |
10340 CAMINO SANTA FE | SAN DIEGO | CA | 92121 |
| K012484 | AMEDITECH, INC. |
10340 CAMINO SANTA FE | SAN DIEGO | CA | 92121 |
| K113046 | AMEDITECH, INC. |
10340 CAMINO SANTA FE | SAN DIEGO | CA | 92121 |
| K050186 | AMEDITECH, INC. |
10340 CAMINO SANTA FE | SAN DIEGO | CA | 92121 |
| K981705 | AMERICAN BIO MEDICA CORP. |
1001 G STREET, NW | WASHINGTON | DC | 20001 |
| K983770 | AMERICAN BIO MEDICA CORP. |
1001 G STREET, NW | WASHINGTON | DC | 20001 |
| K021114 | AMERICAN BIO MEDICA CORP. |
9110 RED BRANCH RD. | COLUMBIA | MD | 21045 |
| K992033 | AMERICAN BIO MEDICA CORP. |
1001 G STREET, NW | WASHINGTON | DC | 20001 |
| K002447 | AMERICAN BIO MEDICA CORP. |
1001 G STREET, NW | WASHINGTON | DC | 20001 |
| K012159 | AMERICAN BIO MEDICA CORP. |
163 CABOT ST. | BEVERLY | MA | 01915 |
| K984525 | AMERICAN BIO MEDICA CORP. |
300 FAIRVIEW AVE. | HUDSON | NY | 12534 |
| K041696 | AMERICAN BIO MEDICA CORP. |
163 CABOT ST. | BEVERLY | MA | 01915 |
| K053359 | AMERICAN BIO MEDICA CORP. |
163 CABOT ST. | BEVERLY | MA | 01915 |
| K981504 | AMERITEK, INC. |
7030 35TH AVE., N.E. | SEATTLE | WA | 98115 |
| K990681 | AMERITEK, INC. |
7030 35TH AVE., N.E. | SEATTLE | WA | 98115 |
| K061005 | APPLIED DNA TECHNOLOGIES, INC. |
26251 VERONA PLACE | MISSION VIEJO | CA | 92692 |
| K973726 | APPLIED TECHNOLOGY VENTURES, L.L.C. |
2190 FOX MILL RD., STE. 200 | HERNDON | VA | 20171 |
| K153465 | Assure Tech (Hangzhou) Co., Ltd. |
No. 10, Xiyuansan Rd., Westlake Economic Zone | Hangzhou | 310030 | |
| K191099 | Atlas Medical |
King Abdullah Industrial Estate, Sahab free zone Area | Amman | ||
| K000606 | BECKMAN COULTER, INC. |
200 S. KRAEMER BLVD.,M/S W-104 | BREA | CA | 92822-8000 |
| K141748 | BIOPHOR DIAGNOSTICS, INC. |
1201 DOUGLAS AVE | REDWOOD CITY | CA | 94063 |
| K014247 | BIOSITE INCORPORATED |
11030 ROSELLE ST. | SAN DIEGO | CA | 92121 |
| K955934 | BIOSITE INCORPORATED |
11030 ROSELLE ST. | SAN DIEGO | CA | 92121 |
| K973784 | BIOSITE INCORPORATED |
11030 ROSELLE ST. | SAN DIEGO | CA | 92121 |
| K955935 | BIOSITE INCORPORATED |
11030 ROSELLE ST. | SAN DIEGO | CA | 92121 |
| K012745 | BIOSITE INCORPORATED |
11030 ROSELLE ST. | SAN DIEGO | CA | 92121 |
| K040203 | BRANAN MEDICAL CORP. |
10015 MUIRLANDS RD., SUITE E | IRVINE | CA | 92618 |
| K004034 | BRANAN MEDICAL CORP. |
10015 MUIRLANDS RD., SUITE E | IRVINE | CA | 92618 |
| K002266 | BRANAN MEDICAL CORPORATION |
10015 MUIRLANDS RD. SUITE E | IRVINE | CA | 92618 |
| K142580 | CHEMTRON BIOTECH, INC. |
9245 BROWN DEER ROAD, SUITE B | SAN DIEGO | CA | 92121 |
| K102203 | CHEMTRON BIOTECH, INC. |
8370 JUNIPER CREEK LANE | SAN DIEGO | CA | 92126 |
| K121339 | CHEMTRON BIOTECH, INC. |
9245 Brown Deer Rd | San Diego | CA | 92121 |
| K131110 | CO-INNOVATION BIOTECH CO., LTD. |
NO. 13 YANYUAN ROAD. TIANHE DISTRICT | GUANGZHOU, GUANGDONG | 510507 | |
| K142800 | Co-Innovation Biotech Co., Ltd. |
No. 13, Yanyuan Road, Tianhe District | Guangzhou | 510507 | |
| K152590 | CORETESTS, INC |
6190 YARROW DRIVE | CARLSBAD | CA | 92011 |
| K053337 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY | NEWARK | DE | 19714-6101 |
| K043028 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K031004 | DADE BEHRING, INC. |
500 GBC DR. | NEWARK | DE | 19702 |
| K000460 | DADE BEHRING, INC. |
RT. 896, GLASCOW BLDG. 500 | NEWARK | DE | 19714 |
| K040133 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY; | NEWARK | DE | 19714-6101 |
| K992632 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K970265 | DRIAL CONSULTANTS, INC. |
1445 LOS ANGELES AVE., SUITE | SIMI VALLEY | CA | 93065 |
| K970724 | DRIAL CONSULTANTS, INC. |
1420 LOS ANGELES AVE. STE 201 | SIMI VALLEY | CA | 93065 |
| K971109 | DRIAL CONSULTANTS, INC. |
1420 LOS ANGELES AVE. STE 201 | SIMI VALLEY | CA | 93065 |
| K971218 | DRIAL CONSULTANTS, INC. |
1420 LOS ANGELES AVE. STE 201 | SIMI VALLEY | CA | 93065 |
| K970395 | DRIAL CONSULTANTS, INC. |
1420 LOS ANGELES AVE. STE 201 | SIMI VALLEY | CA | 93065 |
| K000400 | DRUG DETECTION DEVICES, LTD. |
6820 MEADOWRIDGE COURT | ALPHARETTA | GA | 30005 |
| K052115 | FIRST CHECK DIAGNOSTICS LLC |
13 SPECTRUM POINTE DR. | LAKE FOREST | CA | 92630 |
| K130082 | GENPRIME, INC |
1983 HAZELWOOD ROAD | TOMS RIVER | NJ | 08753 |
| K141532 | Guangzhou Wondfo Biotech Co., Ltd. |
504 EAST DIAMOND AVE. | GAITHERSBURG | MD | 20878 |
| K122961 | Guangzhou Wondfo Biotech Co., Ltd. |
504 EAST DIAMOND AVE. | SUITE F GAITHERSBURG | MD | 20877 |
| K121987 | Guangzhou Wondfo Biotech Co., Ltd. |
504 EAST DIAMOND AVE. | SUITE F GAITHERSBURG | MD | 20877 |
| K111560 | Guangzhou Wondfo Biotech Co., Ltd. |
504 EAST DIAMOND AVE. | GAITHERSBRUG | MD | 20878 |
| K122904 | Guangzhou Wondfo Biotech Co., Ltd. |
504 EAST DIAMOND AVE. | GAITHERSBRUG | MD | 20878 |
| K133968 | Guangzhou Wondfo Biotech Co., Ltd. |
504 EAST DIAMOND AVE. | GAITHERSBURG | MD | 20878 |
| K182738 | Hangzhou AllTest Biotech Co., Ltd |
#550, Yinhai Street | Hangzhou | 310018 | |
| K161251 | Hangzhou Clongene Biotech Co., Ltd |
Building 4, No. 20 Longquan Road, | Hangzhou | 311121 | |
| K152269 | HEALGEN SCIENTIFIC LLC |
5213 MAPLE STREET | BELLAIRE | TX | 77401 |
| K051579 | Immunalysis Corporation |
829 TOWNE CENTER DR. | POMONA | CA | 91767 |
| K143500 | Immunalysis Corporation |
829 Towne Center Drive | Pomona | CA | 91767 |
| K060810 | IND DIAGNOSTIC INC. |
1629 FOSTERS WAY | DELTA, BC | V3M 6S7 | |
| K061718 | INNOVACON, INC. |
4106 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K020395 | Lin-Zhi International, Inc. |
2391 ZANKER RD., SUITE 340 | SAN JOSE | CA | 95131-1124 |
| K033094 | Lin-Zhi International, Inc. |
687 NORTH PASTORIA AVE. | SUNNYVALE | CA | 94085-2917 |
| K063024 | Lin-Zhi International, Inc. |
687 NORTH PASTORIA AVE. | SUNNYVALE | CA | 94085-2917 |
| K102210 | Lin-Zhi International, Inc. |
670 ALmanor Avenue | Sunnyvale | CA | 94085 |
| K131653 | Lin-Zhi International, Inc. |
670 ALmanor Avenue | Sunnyvale | CA | 94085 |
| K080635 | MEDTOX DIAGNOSTICS, INC. |
1238 ANTHONY RD. | BURLINGTON | NC | 27215 |
| K050394 | MEDTOX DIAGNOSTICS, INC. |
1238 ANTHONY RD. | BURLINGTON | NC | 27215 |
| K010564 | MEDTOX DIAGNOSTICS, INC. |
1238 ANTHONY RD. | BURLINGTON | NC | 27215 |
| K011952 | MICRODIAGNOSTICS, INC. |
28062 FORBES ROAD, SUITE B | LAGUNA NIGUEL | CA | 92677 |
| K974611 | MICRODIAGNOSTICS, INC. |
28062 FORBES ROAD, SUITE B | LAGUNA NIGUEL | CA | 92677 |
| K994380 | MICROGENICS CORP. |
46360 FREMONT BLVD. | FREMONT | CA | 94538 |
| K012110 | MICROGENICS CORP. |
46360 FREMONT BLVD. | FREMONT | CA | 94538 |
| K101745 | MICROGENICS CORP. |
46360 FREMONT BLVD | FREMONT | CA | 94538 |
| K093114 | MICROGENICS CORP. |
46360 FREMONT BLVD | FREMONT | CA | 94538 |
| K080057 | NOVX SYSTEMS INC. |
16809 BRIARDALE ROAD | ROCKVILLE | MD | 20853 |
| K142855 | Omega Laboratories, Inc. |
400 N. Cleveland Ave. | Mogadore | OH | 44260 |
| K992918 | ORASURE TECHNOLOGIES, INC. |
1745 EATON AVE. | BETHLEHEM | PA | 18018-1799 |
| K972989 | ORASURE TECHNOLOGIES, INC. |
1745 EATON AVE. | BETHLEHEM | PA | 18018-1799 |
| K062077 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K011609 | PAN PROBE BIOTECH, INC. |
8515 ARJONS DR., SUITE A | SAN DIEGO | CA | 92126 |
| K994237 | PHAMATECH |
9265 ACTIVITY RD., #112-113 | SAN DIEGO | CA | 92126 |
| K010645 | PHAMATECH |
9530 PADGETT ST. #101 | SAN DIEGO | CA | 92126 |
| K001397 | PHAMATECH |
9265 ACTIVITY RD., #112-113 | SAN DIEGO | CA | 92126 |
| K980865 | PHAMATECH |
9265 ACTIVITY RD., #112-113 | SAN DIEGO | CA | 92126 |
| K131069 | PHAMATECH INC. |
10151 BARNES CANYON RD | SAN DIEGO | CA | 92121 |
| K181945 | Phamatech Inc. |
15175 Innovation Drive | San Diego | CA | 92128 |
| K121065 | POLYMED THERAPEUTICS, INC |
12828 DOE LANE | GAITHERSBURG | MD | 20878 |
| K001225 | PRINCETON BIOMEDITECH CORP. |
4242 U.S. RT. 1 | MONMOUTH JUNCTION | NJ | 08852-1905 |
| K130811 | PSYCHEMEDICS CORP. |
5832 UPLANDER WAY | CULVER CITY | CA | 90230 |
| K051161 | QUEST DIAGNOSTICS, INC. |
4230 BURNHAM AVE. | LAS VEGAS | NV | 89119-5410 |
| K182719 | Quidel Cardiovascular Inc. |
9975 Summers Ridge Road | San Diego | CA | 92121 |
| K200363 | Quidel Cardiovascular Inc. |
9975 Summers Ridge Road | San Diego | CA | 92121 |
| K040350 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K092275 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K033566 | RAPID DIAGNOSTICS, INC. |
9418 LASAINE AVE. | NORTHRIDGE | CA | 91325 |
| K003809 | RAPID DIAGNOSTICS, INC. |
1429 ROLLINS RD. | BURLINGAME | CA | 94010 |
| K972891 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
1080 U.S. HIGHWAY 202 | BRANCHBURG | NJ | 08876-3771 |
| K983699 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
BRANCHBURG TOWNSHIP | SOMERVILLE | NJ | 08876-3771 |
| K962411 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
BRANCHBURG TOWNSHIP | SOMERVILLE | NJ | 08876-3771 |
| K973075 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
1080 U.S. HIGHWAY 202 | BRANCHBURG | NJ | 08876-3771 |
| K110446 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K083764 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K093664 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K003865 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K012396 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46256 |
| K001421 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K001417 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K990399 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K990337 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K990418 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K180879 | SHANGHAI VENTURE BIO-TECH CO., LTD. |
Room 313, Building 2, No. 2715 Longwu Road, Xuhui District | Shanghai | 200231 | |
| K021006 | STARPLEX SCIENTIFIC, INC. |
163 CABOT ST. | BEVERLY | MA | 01915 |
| K011499 | SUN BIOMEDICAL LABORATORIES, INC. |
604 VPR CENTER | BLACKWOOD | NJ | 08012 |
| K010177 | SUN BIOMEDICAL LABORATORIES, INC. |
604 VPR CENTER | BLACKWOOD | NJ | 08012 |
| K972032 | SUN BIOMEDICAL LABORATORIES, INC. |
2040 FAIRFAX AVE. | CHERRY HILL | NJ | 08003 |
| K990325 | SYNTRON BIORESEARCH, INC. |
1420 LOS ANGELES AVE. | SIMI VALLEY | CA | 93065 |
| K012257 | SYVA CO. |
20400 MARIANI AVE. | CUPERTINO | CA | 95014 |
| K981197 | TCPI, INC. |
P.O. BOX 8726 | FT. LAUDERDALE | FL | 33310 |
| K061617 | Tianjin New Bay Bioresearch Co., Ltd. |
3108 AVENIDA OLMEDA | CARLSBAD | CA | 92009 |
| K052882 | Tianjin New Bay Bioresearch Co., Ltd. |
3108 AVENIDA OLMEDA | CARLSBAD | CA | 92009 |
| K071489 | Tianjin New Bay Bioresearch Co., Ltd. |
3108 AVENIDA OLMEDA | CARLSBAD | CA | 92009 |
| K152908 | UCP BIOSCIENCES, INC |
1445 KOLL CIRCLE | SAN JOSE | CA | 95112 |
| K151213 | UCP BIOSCIENCES, INC |
1445 KOLL CIRCLE, STE 111 | SAN JOSE | CA | 95112 |
| K123863 | UCP BIOSCIENCES, INC. |
1445 KOLL CIRCLE, STE. 111 | SAN JOSE | CA | 95112 |
| K131811 | UCP BIOSCIENCES, INC. |
1445 KOLL CIRCLE, STE. 111 | SAN JOSE | CA | 95112 |
| K122419 | UCP BIOSCIENCES, INC. |
1445 KOLL CIRCLE, STE. 111 | SAN JOSE | CA | 95112 |
| K130463 | UCP BIOSCIENCES, INC. |
1445 KOLL CIRCLE, STE. 111 | SAN JOSE | CA | 95112 |
| K091588 | UCP BIOSCIENCES, INC. |
1445 KOLL CIRCLE, STE. 111 | SAN JOSE | CA | 95112 |
| K132812 | UCP BIOSCIENCES, INC. |
1445 KOLL CIRCLE, STE. 111 | SAN JOSE | CA | 95112 |
| K050540 | UCP BIOSCIENCES, INC. |
1445 KOLL CIRCLE, STE. 111 | SAN JOSE | CA | 95112 |
| K051235 | VARIAN INC |
25200 COMMERCENTRE DR. | LAKE FOREST | CA | 92630-8810 |
| K033902 | VARIAN INC |
25200 COMMERCENTRE DR. | LAKE FOREST | CA | 92630-8810 |
| K033659 | VARIAN INC |
25200 COMMERCENTRE DR. | LAKE FOREST | CA | 92630-8810 |
| K032575 | W.H.P.M., INC. |
163 CABOT ST. | BEVERLY | MA | 01915 |
| K020869 | WORLDWIDE MEDICAL CORP. |
13 SPECTRUM POINTE DR. | LAKE FOREST | CA | 92630 |
| K051966 | WORLDWIDE MEDICAL LLC |
13 SPECTRUM POINTE DR. | LAKE FOREST | CA | 92630 |
| K231137 | Xenta Biomedical Science Co., Ltd. |
Building C5, 9th Floor, Rm 901, No. 11 Kaiyuan Avenue, | Guangzhou | 510535 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
