K896635 is an FDA 510(k) clearance for the VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY. This device is classified as a Antisera, Cf, Influenza Virus A, B, C (Class I - General Controls, product code GNW).
Submitted by Baxter Healthcare Corp (Bellevue, US). The FDA issued a Cleared decision on February 2, 1990, 72 days after receiving the submission on November 22, 1989.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3330.
| 510(k) Number | K896635 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 1989 |
| Decision Date | February 02, 1990 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GNW — Antisera, Cf, Influenza Virus A, B, C |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3330 |