FDA 510(k) Applications for Medical Device:
Discs, Strips And Reagents, Microorganism Differentiation
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K050352 | AMERITEK RESEARCH LLC |
15205 3RD DR. SE | MILL CREEK | WA | 98012 |
| K954783 | DIFCO LABORATORIES, INC. |
17197 N. LAUREL PARK | LIVOUIA | MI | 48152 |
| K955826 | GIBSON LABORATORIES, INC. |
1040 MANCHESTER ST. | LEXINGTON | KY | 40508 |
| K961191 | HARDY DIAGNOSTICS |
1430 WEST MCCOY LN. | SANTA MARIA | CA | 93455 |
| K960996 | HARDY DIAGNOSTICS |
1430 WEST MCCOY LN. | SANTA MARIA | CA | 93455 |
| K962966 | INNOVATIVE DIAGNOSTIC SYSTEMS, INC. |
2797 PETERSON PLACE | NORCROSS | GA | 30071 |
| K970009 | MICRO BIO LOGICS, INC. |
217 OSSEO AVE. NORTH | ST. CLOUD | MN | 56303-4452 |
| K970834 | REMEL, INC. |
12076 SANTA FE DR. | LENEXA | KS | 66215-3594 |
| K970833 | REMEL, INC. |
12076 SANTA FE DR. | LENEXA | KS | 66215-3594 |
| K970832 | REMEL, INC. |
12076 SANTA FE DR. | LENEXA | KS | 66215-3594 |
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