K924006 is an FDA 510(k) clearance for the BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY. 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 Baxter Healthcare Corp (Issauah, US). The FDA issued a Cleared decision on December 29, 1992, 141 days after receiving the submission on August 10, 1992.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3330.
| 510(k) Number | K924006 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 1992 |
| Decision Date | December 29, 1992 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| 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 |