K913214 is an FDA 510(k) clearance for the INFLUENZA MAB TEST/INFLUENZA B TEST. This device is classified as a Antisera, Cf, Influenza Virus A, B, C (Class I - General Controls, product code GNW).
Submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 13, 1991, 147 days after receiving the submission on July 19, 1991.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3330.
| 510(k) Number | K913214 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 1991 |
| Decision Date | December 13, 1991 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GNW — Antisera, Cf, Influenza Virus A, B, C |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3330 |