FDA 510(k) Applications for Medical Device:
Enzyme Immunoassay, Phencyclidine
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K013096 | ABBOTT LABORATORIES |
1920 HURD DR. | IRVING | TX | 75038 |
| K011730 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K060353 | ACRO BIOTECH LLC. |
9500 7TH STREET UNIT M | RANCHO CUCAMONGA | CA | 91730-9094 |
| K010047 | ALFA SCIENTIFIC DESIGNS, INC. |
12330 STOWE DR. | POWAY | CA | 92064 |
| K010045 | ALFA SCIENTIFIC DESIGNS, INC. |
12330 STOWE DR. | POWAY | CA | 92064 |
| K023109 | AMEDICA BIOTECH, INC. |
28301 INDUSTRIAL BLVD SUITE K | HAYWARD | CA | 94545 |
| K012582 | AMEDITECH, INC. |
10340 CAMINO SANTA FE | SAN DIEGO | CA | 92121 |
| K993945 | BIONIKE LABORATORIES, INC. |
1420 LOS ANGELES AVE. | SIMI VALLEY | CA | 93065 |
| K122703 | BIOPHOR DIAGNOSTICS, INC. |
1201 DOUGLAS AVE | REDWOOD CITY | CA | 94063 |
| K972963 | BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. | CONCORD | CA | 94524 |
| K002272 | BRANAN MEDICAL CORP. |
10015 MUIRLANDS RD., SUITE E | IRVINE | CA | 92618 |
| K000462 | DADE BEHRING, INC. |
RT. 896, GLASCOW BLDG. 500 | NEWARK | DE | 19714 |
| K000402 | DRUG DETECTION DEVICES, LTD. |
6820 MEADOWRIDGE COURT | ALPHARETTA | GA | 30005 |
| K963233 | EDITEK, INC. |
1238 ANTHONY RD. | BURLINGTON | NC | 27215 |
| K963692 | EDITEK, INC. |
1238 ANTHONY RD. | BURLINGTON | NC | 27215 |
| K142044 | Guangzhou Wondfo Biotech Co., Ltd. |
504 EAST DIAMOND AVE. | GAITHERSBURG | MD | 20878 |
| K152176 | Immunalysis Corporation |
829 Towne Center Drive | Pomona | CA | 91767 |
| K181135 | Immunalysis Corporation |
829 Towne Center Drive | Pomona | CA | 91767 |
| K203489 | Immunalysis Corporation |
829 Towne Center Drive | Pomona | CA | 91767 |
| K020254 | Lin-Zhi International, Inc. |
2391 ZANKER RD. SUITE 340 | SAN JOSE | CA | 95131 |
| K002776 | MEDTOX DIAGNOSTICS, INC. |
1238 ANTHONY RD. | BURLINGTON | NC | 27215 |
| K991505 | MICRODIAGNOSTICS, INC. |
28062 FORBES ROAD, SUITE B | LAGUNA NIGUEL | CA | 92677 |
| K101746 | MICROGENICS CORP. |
46360 FREMONT BLVD | FREMONT | CA | 94538 |
| K131181 | OMEGA LABORATORIES, INC. |
400 NORTH CLEVELAND | MOGADORE | OH | 44260 |
| K101059 | OMEGA LABORATORIES, INC. |
PO BOX 506 | SOUTH LYON | MI | 48178 |
| K982801 | ORASURE TECHNOLOGIES, INC. |
1745 EATON AVE. | BETHLEHEM | PA | 18018-1799 |
| K000399 | ORASURE TECHNOLOGIES, INC. |
1745 EATON AVE. | BETHLEHEM | PA | 18018-1799 |
| K062094 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K012107 | PAN PROBE BIOTECH, INC. |
8515 ARJONS DR., SUITE A | SAN DIEGO | CA | 92126 |
| K994236 | PHAMATECH |
9265 ACTIVITY RD., #112-113 | SAN DIEGO | CA | 92126 |
| K010651 | PHAMATECH |
9530 PADGETT ST. #101 | SAN DIEGO | CA | 92126 |
| K974582 | PHAMATECH |
9265 ACTIVITY RD., #112-113 | SAN DIEGO | CA | 92126 |
| K041578 | PHAMATECH |
10151 BARNES CANYON ROAD | SAN DIEGO | CA | 92121 |
| K961266 | PRINCETON BIOMEDITECH CORP. |
4242 U.S. ROUTE 1 | MONMOUTH JUNCTION | NJ | 08852-1905 |
| K111928 | PSYCHEMEDICS CORP. |
5832 UPLANDER WAY | CULVER CITY | CA | 90230 |
| K212952 | Psychemedics Corporation |
5832 Uplander Way | Culver City | CA | 90230 |
| K080431 | QUANTRX BIOMEDICAL CORPORATION |
13721 VIA TRES VISTA | SAN DIEGO | CA | 92129 |
| K042726 | QUEST DIAGNOSTICS, INC. |
4230 BURNHAM AVE. | LAS VEGAS | NV | 89119-5410 |
| K043071 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K991698 | REDWOOD BIOTECH, INC. |
2440 LEGHORN ST. | MOUNTAIN VIEW | CA | 94043 |
| K964355 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
1080 U.S. HIGHWAY 202 | BRANCHBURG | NJ | 08876-3771 |
| K093989 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K043305 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K994017 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K994030 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K994020 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K163220 | Siemens Healthcare Diagnostics, Inc. |
500 GBC Drive, PO Box 6101 MS 514 | Newark | DE | 19711 |
| K983790 | SUN BIOMEDICAL LABORATORIES, INC. |
604 VPR CENTER | BLACKWOOD | NJ | 08012 |
| K981292 | SYNTRON BIORESEARCH, INC. |
1420 LOS ANGELES AVE. | SIMI VALLEY | CA | 93065 |
| K981019 | SYNTRON BIORESEARCH, INC. |
1420 LOS ANGELES AVE. | SIMI VALLEY | CA | 93065 |
| K993983 | SYVA CO. |
3403 YERBA BUENA RD. | SAN JOSE | CA | 95161-9013 |
| K011161 | SYVA CO., DADE BEHRING, INC. |
3403 YERBA BUENA RD. | SAN JOSE | CA | 95135 |
| K981363 | TCPI, INC. |
P.O. BOX 8726 | FT. LAUDERDALE | FL | 33310 |
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