FDA 510(k) Applications for Medical Device:
Enzyme Immunoassay, Valproic Acid
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K090358 | ABBOTT LABORATORIES INC |
100 ABBOTT PARK ROAD | ABBOTT PARK | IL | 60064 |
| K964442 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K042807 | BAYER HEALTHCARE, LLC |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K031870 | BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110 | BREA | CA | 92822 |
| K961256 | BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD., W-337 | BREA | CA | 92622-8000 |
| K982880 | DADE BEHRING, INC. |
BLDG. 500 MAIL BOX 514 | NEWARK | DE | 19714-6101 |
| K002551 | DADE BEHRING, INC. |
3403 YERBA BUENA RD. | SAN JOSE | CA | 95161-9013 |
| K000005 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K961988 | DIAGNOSTIC REAGENTS, INC. |
601 CALIFORNIA AVE. | SUNNYVALE | CA | 94086 |
| K042476 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K011649 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K060690 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K032049 | ROCHE DIAGNOSTICS CORP. |
P.O. BOX 50457 | INDIANAPOLIS | IN | 46250-0457 |
| K973581 | SCHIAPPARELLI BIOSYSTEMS, INC. |
368 PASSAIC AVE. | FAIRFIELD | NJ | 07004 |
| K030405 | SERADYN |
7998 GEORGETOWN RD. | INDIANAPOLIS | IN | 46268 |
| K972132 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
| K011947 | SYVA CO. |
20400 MARIANI AVE. | CUPERTINO | CA | 95014 |
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