K901493 is an FDA 510(k) clearance for the FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B. This device is classified as a Antigens, Cf (including Cf Control), Influenza Virus A, B, C (Class I - General Controls, product code GNX).
Submitted by Whittaker Bioproducts, Inc. (Walkersville, US). The FDA issued a Cleared decision on June 27, 1990, 90 days after receiving the submission on March 29, 1990.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3330.
| 510(k) Number | K901493 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 1990 |
| Decision Date | June 27, 1990 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GNX — Antigens, Cf (including Cf Control), Influenza Virus A, B, C |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3330 |