FDA 510(k) Applications for Medical Device:
Enzyme Immunoassay, Theophylline
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K013272 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K961462 | BOEHRINGER MANNHEIM CORP. |
2380A BISSO LN. | CONCORD | CA | 94520 |
| K972495 | CHEMTRAK, INC. |
929 EAST ARQUES AVE. | SUNNYVALE | CA | 94086-4520 |
| K042407 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K042520 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K011771 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K020740 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K973583 | SCHIAPPARELLI BIOSYSTEMS, INC. |
368 PASSAIC AVE. | FAIRFIELD | NJ | 07004 |
| K993029 | SYVA CO. |
3403 YERBA BUENA RD. | SAN JOSE | CA | 95161-9013 |
| K011166 | SYVA CO., DADE BEHRING, INC. |
3403 YERBA BUENA RD. | SAN JOSE | CA | 95135 |
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