FDA 510(k) Applications for Medical Device:
Enzyme Immunoassay, Benzodiazipine
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K013143 | ABBOTT LABORATORIES |
DEPT. 09VA LC-2 | IRVING | TX | 75038 |
| K012300 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K060354 | ACRO BIOTECH LLC. |
9500 7TH STREET UNIT M | RANCHO CUCAMONGA | CA | 91730-9094 |
| K003881 | ALFA SCIENTIFIC DESIGNS, INC. |
12330 STOWE DR. | POWAY | CA | 92064 |
| K003879 | ALFA SCIENTIFIC DESIGNS, INC. |
12330 STOWE DR. | POWAY | CA | 92064 |
| K992720 | AMERICAN BIO MEDICA CORP. |
1001 G STREET, NW | WASHINGTON | DC | 20001 |
| K023048 | BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110 | BREA | CA | 92822 |
| K051307 | BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110 | BREA | CA | 92822 |
| K043556 | BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110 | BREA | CA | 92822 |
| K962734 | BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. | CONCORD | CA | 94524-4117 |
| K002342 | BRANAN MEDICAL CORPORATION |
10015 MUIRLANDS RD. SUITE E | IRVINE | CA | 92618 |
| K111322 | CHEMTRON BIOTECH, INC. |
8370 JUNIPER CREEK LANE | SAN DIEGO | CA | 92126 |
| K123080 | CHEMTRON BIOTECH, INC. |
8370 JUNIPER CREEK LANE | SAN DIEGO | CA | 92126 |
| K000458 | DADE BEHRING, INC. |
RT. 896, GLASCOW BLDG. 500 | NEWARK | DE | 19714 |
| K960708 | DIAGNOSTIC REAGENTS, INC. |
601 CALIFORNIA AVE. | SUNNYVALE | CA | 94086 |
| K973326 | DRIAL CONSULTANTS, INC. |
1420 LOS ANGELES AVE. STE 201 | SIMI VALLEY | CA | 93065 |
| K973269 | DRIAL CONSULTANTS, INC. |
1420 LOS ANGELES AVE. STE 201 | SIMI VALLEY | CA | 93065 |
| K000449 | DRUG DETECTION DEVICES, LTD. |
6820 MEADOWRIDGE COURT | ALPHARETTA | GA | 30005 |
| K151642 | HEALGEN SCIENTIFIC LLC |
5213 MAPLE ST | BELLAIRE | TX | 77401 |
| K153597 | HEALGEN SCIENTIFIC LLC |
5213 MAPLE ST | BELLAIRE | TX | 77401 |
| K150356 | HEALGEN SCIENTIFIC LLC |
5213 MAPLE STREET | BELLAIRE | TX | 77401 |
| K163704 | HEALGEN SCIENTIFIC LLC |
5213 Maple St. | Bellaire | TX | 77401 |
| K151771 | IMMUNALYSIS CORPORATION |
829 TOWNE CENTER DR | POMONA | CA | 91767 |
| K032365 | Lin-Zhi International, Inc. |
687 NORTH PASTORIA AVE. | SUNNYVALE | CA | 94085-2917 |
| K243498 | Microgenics Corporation |
46500 Kato Road | Fremont | CA | 94538 |
| K190968 | Microgenics Corporation |
45600 Kato Road | Fremont | CA | 94538 |
| K173963 | Microgenics Corporation |
46500 Kato Road | Fremont | CA | 94538 |
| K982831 | ORASURE TECHNOLOGIES, INC. |
1745 EATON AVE. | BETHLEHEM | PA | 18018-1799 |
| K013882 | ORASURE TECHNOLOGIES, INC. |
1745 EATON AVE. | BETHLEHEM | PA | 18018-1799 |
| K062285 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K012131 | PAN PROBE BIOTECH, INC. |
8515 ARJONS DR., SUITE A | SAN DIEGO | CA | 92126 |
| K981687 | PHAMATECH |
9265 ACTIVITY RD., #112-113 | SAN DIEGO | CA | 92126 |
| K043167 | PHAMATECH INC. |
10151 BARNES CANYON RD | SAN DIEGO | CA | 92121 |
| K962672 | PRINCETON BIOMEDITECH CORP. |
4242 U.S. RT. 1 | MONMOUTH JUNCTION | NJ | 08852-1905 |
| K991079 | PRINCETON BIOMEDITECH CORP. |
4242 U.S. ROUTE 1 | MONMOUTH JUNCTION | NJ | 08852-1905 |
| K974181 | PRINCETON BIOMEDITECH CORP. |
4242 U.S. RT. 1 | MONMOUTH JUNCTION | NJ | 08852-1905 |
| K961325 | PRINCETON BIOMEDITECH CORP. |
4242 U.S. ROUTE 1 | MONMOUTH JUNCTION | NJ | 08852-1905 |
| K163590 | Psychemedics Corporation |
5832 Uplander Way | Culver City | CA | 90230 |
| K092274 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K050179 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K983702 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
BRANCHBURG TOWNSHIP | SOMERVILLE | NJ | 08876-3771 |
| K983174 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
1080 U.S. HIGHWAY 202 | BRANCHBURG | NJ | 08876-3771 |
| K221765 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K043327 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K991443 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K993985 | SYVA CO. |
3403 YERBA BUENA RD. | SAN JOSE | CA | 95161-9013 |
| K011306 | SYVA CO., DADE BEHRING, INC. |
3403 YERBA BUENA RD. | SAN JOSE | CA | 95135 |
| K980776 | TCPI, INC. |
1420 LOS ANGELES AVE. | SIMI VALLEY | CA | 93065 |
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