FDA 510(k) Applications for Medical Device:
Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K133411 | ALERE SCARBOROUGH, INC D/B/A BINAX, INC. |
10 Southgate Rd | Scarborough | ME | 04074 |
| K131619 | QUIDEL CORP. |
10165 MCKELLAR CT. | SAN DIEGO | CA | 92121 |
| K131606 | QUIDEL CORP. |
10165 MCKELLAR CT. | SAN DIEGO | CA | 92121 |
| K131599 | QUIDEL CORPORATION |
10165 MCKELLAR COURT | SAN DIEGO | CA | 92121 |
| K131804 | REMEL, INC. |
12076 Santa Fe Trail Dr | LENEXA | KS | 66215 |
| K132352 | SA SCIENTIFIC LTD. |
4919 GOLDEN QUAIL | SAN ANTONIO | TX | 78240 |
| K123182 | SEKISUI DIAGNOSTICS, LLC |
6659 Top Gun St | SAN DIEGO | CA | 92121 |
| K971494 | ZYMETX, INC. |
800 RESEARCH PKWY. | OKLAHOMA CITY | OK | 73104 |
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