FDA 510(k) Applications for Medical Device:
Enzyme Immunoassay, Cannabinoids
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K013247 | ABBOTT LABORATORIES |
DEPT. 09VA LC-2 | IRVING | TX | 75038 |
| K041221 | ACCU-STAT DIAGNOSTICS, INC. |
11 ORCHARD RD., SUITE 108 | LAKE FOREST | CA | 92630 |
| K040629 | ACCU-STAT DIAGNOSTICS, INC. |
11 ORCHARD RD., SUITE 108 | LAKE FOREST | CA | 92630 |
| K003557 | ACON LABORATORIES, INC. |
11175 FLINTKOTE AVE., #F | SAN DIEGO | CA | 92121 |
| K050936 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K050050 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K050878 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K053034 | ACRO BIOTECH LLC. |
9500 7TH STREET UNIT M | RANCHO CUCAMONGA | CA | 91730-9094 |
| K010921 | ADVANTAGE DIAGNOSTICS CORP. |
1201 DOUGLAS AVE. | REDWOOD CITY | CA | 94063 |
| K001567 | ADVANTAGE DIAGNOSTICS CORP. |
1201 DOUGLAS AVE. | REDWOOD CITY | CA | 94063 |
| K001126 | ALATEX SCIENTIFIC, INC. |
2440 LEGHORN ST. | MOUNTIAN VIEW | CA | 94043 |
| K994410 | ALFA SCIENTIFIC DESIGNS, INC. |
11494 SORRENTO VALLEY RD., | SAN DIEGO | CA | 92121 |
| K022955 | AMEDICA BIOTECH, INC. |
28301 INDUSTRIAL BLVD SUITE K | HAYWARD | CA | 94545 |
| K061556 | AMEDICA BIOTECH, INC. |
28301 INDUSTRIAL BLVD SUITE K | HAYWARD | CA | 94545 |
| K040464 | AMEDICA BIOTECH, INC. |
28301 INDUSTRIAL BLVD SUITE K | HAYWARD | CA | 94545 |
| K080872 | AMEDICA BIOTECH, INC. |
28301 INDUSTRIAL BLVD SUITE K | HAYWARD | CA | 94545 |
| K011813 | AMEDITECH, INC. |
10340 CAMINO SANTA FE | SAN DIEGO | CA | 92121 |
| K993961 | AMERICAN BIO MEDICA CORP. |
122 SMITH RD. | KINDERHOOK | NY | 12106 |
| K993796 | AMERICAN BIO MEDICA CORP. |
300 FAIRVIEW AVE. | HUDSON | NY | 12534 |
| K990818 | AMERICAN BIO MEDICA CORP. |
1001 G STREET, NW | WASHINGTON | DC | 20001 |
| K983188 | AMERITEK, INC. |
7030 35TH AVE., N.E. | SEATTLE | WA | 98115 |
| K080467 | APPLIED DNA TECHNOLOGIES, INC. |
26251 VERONA PLACE | MISSION VIEJO | CA | 92692 |
| K980836 | APPLIED TECHNOLOGY VENTURES, L.L.C. |
6 TAFT CT., SUITE 150 | ROCKVILLE | MD | 20850 |
| K955677 | BECKMAN INSTRUMENTS, INC. |
200 S. KRAEMER BLVD., W-337 | BREA | CA | 92622-8000 |
| K971841 | BIONIKE LABORATORIES, INC. |
1015 GRANDVIEW DR. | SOUTH SAN FRANCISCO | CA | 94080-4910 |
| K132096 | BIOPHOR DIAGNOSTICS, INC. |
1201 DOUGLAS AVE | REDWOOD CITY | CA | 94063 |
| K954497 | BOEHRINGER MANNHEIM CORP. |
1700 ROCKVILLE PIKE | ROCKVILLE | MD | 20852 |
| K002263 | BRANAN MEDICAL CORP. |
10015 MUIRLANDS RD., SUITE E | IRVINE | CA | 92618 |
| K012541 | BRANAN MEDICAL CORP. |
10015 MUIRLANDS RD., SUITE E | IRVINE | CA | 92618 |
| K122633 | BRANAN MEDICAL CORP. |
140 Technology Dr Ste 400 | IRVINE | CA | 92618 |
| K000461 | DADE BEHRING, INC. |
RT. 896, GLASCOW BLDG. 500 | NEWARK | DE | 19714 |
| K963916 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K963207 | DRIAL CONSULTANTS, INC. |
1330 O'BRIEN DR. | MENLO PARK | CA | 94025 |
| K992949 | DRUG DETECTION DEVICES, LTD. |
6820 MEADOWRIDGE COURT | ALPHARETTA | GA | 30005 |
| K012390 | DRUG FREE ENTERPRISES |
1627 S GRANVILLE AVE. SUITE 3 | WEST LOS ANGELES | CA | 90025 |
| K963516 | EDITEK, INC. |
1238 ANTHONY RD. | BURLINGTON | NC | 27215 |
| K110182 | Guangzhou Wondfo Biotech Co., Ltd. |
504 EAST DIAMOND AVE. | GAITHERSBURG | MD | 20878 |
| K121557 | Guangzhou Wondfo Biotech Co., Ltd. |
504 EAST DIAMOND AVE. | SUITE F GAITHERSBURG | MD | 20877 |
| K153741 | HANGZHOU CLONGENE BIOTECH CO., LTD. |
BUILDING 4, NO.20 LONGQUAN ROAD | HANGZHOU | 311121 | |
| K223162 | Healgen Scientific LLC |
5213 Maple St | Bellaire | TX | 77401 |
| K140546 | HEALGEN SCIENTIFIC, LLC |
504 EAST DIAMOND AVE. | GAITHERSBURG | MD | 20877 |
| K102428 | HIEN HELEN NGUYEN |
1810 OAKLAND RD., | SAN JOSE | CA | 95131 |
| K151203 | IMMUNALYSIS CORPORATION |
829 TOWNE CENTER DR | POMONA | CA | 91767 |
| K021887 | Lin-Zhi International, Inc. |
2391 ZANKER RD., SUITE 340 | SAN JOSE | CA | 95131-1124 |
| K110239 | Lin-Zhi International, Inc. |
670 ALmanor Avenue | Sunnyvale | CA | 94085 |
| K141320 | Lin-Zhi International, Inc. |
670 ALMANOR AVE. | SUNNYVALE | CA | 94085 |
| K130213 | LUMIQUICK DIAGNOSTICS, INC. |
27001 LA PAZ RD, STE 266B | MISSION VIEJO | CA | 92691 |
| K010138 | MEDTOX DIAGNOSTICS, INC. |
1238 ANTHONY RD. | BURLINGTON | NC | 27215 |
| K991516 | MICRODIAGNOSTICS, INC. |
28062 FORBES ROAD, SUITE B | LAGUNA NIGUEL | CA | 92677 |
| K101744 | MICROGENICS CORP. |
46360 FREMONT BLVD | FREMONT | CA | 94538 |
| K082977 | MK BIO, INC |
10239 FLANDERS CT | SAN DIEGO | CA | 92121 |
| K050594 | NANO-DITECH CO. |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K152643 | NANTONG EGENS BIOTECH CO., LTD. |
BUILDING 15, 1692 XINGHU AVENUE | NANTONG | 226010 | |
| K122759 | OMEGA LABORATORIES, INC. |
400 NORTH CLEVELAND | MOGADORE | OH | 44260 |
| K002375 | ORASURE TECHNOLOGIES, INC. |
1745 EATON AVE. | BETHLEHEM | PA | 18018-1799 |
| K973750 | ORASURE TECHNOLOGIES, INC. |
1745 EATON AVE. | BETHLEHEM | PA | 18018-1799 |
| K063164 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K010001 | PAN PROBE BIOTECH, INC. |
8515 ARJONS DR., SUITE A | SAN DIEGO | CA | 92126 |
| K994220 | PHAMATECH |
9265 ACTIVITY RD., #112-113 | SAN DIEGO | CA | 92126 |
| K973122 | PHAMATECH |
9265 ACTIVITY RD., #112-113 | SAN DIEGO | CA | 92126 |
| K000131 | PHAMATECH |
9265 ACTIVITY RD., #112-113 | SAN DIEGO | CA | 92126 |
| K142408 | POLYMED THERAPEUTICS, INC |
3040 POST OAK BLVD, SUITE 1110 | HOUSTON | TX | 77056 |
| K014193 | PRINCETON BIOMEDITECH CORP. |
4242 U.S. RT. 1 | MONMOUTH JUNCTION | NJ | 08852-1905 |
| K014066 | PRINCETON BIOMEDITECH CORP. |
4242 U.S. RT. 1 | MONMOUTH JUNCTION | NJ | 08852-1905 |
| K111929 | PSYCHEMEDICS CORP. |
5832 UPLANDER WAY | CULVER CITY | CA | 90230 |
| K040257 | QUEST DIAGNOSTICS, INC. |
4230 BURNHAM AVE. | LAS VEGAS | NV | 89119-5410 |
| K092269 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K041142 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K990870 | REDWOOD BIOTECH, INC. |
520 WEDDELL DRIVE, SUITE 8 | SUNNYVALE | CA | 94089 |
| K981584 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
BRANCHBURG TOWNSHIP | SOMERVILLE | NJ | 08876-3771 |
| K981585 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
BRANCHBURG TOWNSHIP | SOMERVILLE | NJ | 08876-3771 |
| K983701 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
BRANCHBURG TOWNSHIP | SOMERVILLE | NJ | 08876-3771 |
| K030213 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K994164 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K192515 | Shenzhen Bioeasy Biotechnology Co.,Ltd. |
No.2-1, Liuxian 1st Road, Xin'an Sub-District | Shenzhen | 518101 | |
| K963606 | SUN BIOMEDICAL LABORATORIES, INC. |
2040 FAIRFAX AVE. | CHERRY HILL | NJ | 08003 |
| K023648 | SUN BIOMEDICAL LABORATORIES, INC. |
604 VPR CENTER | BLACKWOOD | NJ | 08012 |
| K963654 | SYNTRON BIORESEARCH, INC. |
3216 SHERI DR. | SIMI VALLEY | CA | 93063 |
| K993984 | SYVA CO. |
3403 YERBA BUENA RD. | SAN JOSE | CA | 95161-9013 |
| K011300 | SYVA CO., DADE BEHRING, INC. |
3403 YERBA BUENA RD. | SAN JOSE | CA | 95135 |
| K951853 | TCPI, INC. |
3341 S.W. 15TH ST. | POMPANO BEACH | FL | 33069 |
| K970548 | TECO DIAGNOSTICS |
4925 EAST HUNTER AVE. | ANAHEIM | CA | 92807 |
| K973154 | UNITED BIOTECH, INC. |
110 PIONEER WAY, #C | MOUNTAIN VIEW | CA | 94041-1517 |
| K993663 | WORLDWIDE MEDICAL CORP. |
1900 K STREET, N.W. | WASHINGTON | DC | 20006-1108 |
| K994139 | WORLDWIDE MEDICAL CORP. |
1900 K STREET, N.W. | WASHINGTON | DC | 20006-1108 |
| K994138 | WORLDWIDE MEDICAL CORP. |
1900 K STREET, N.W. | WASHINGTON | DC | 20006-1108 |
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