K760881 is an FDA 510(k) clearance for the FEBRILE ANTIGEN CONTROL SERA. This device is classified as a Antigens, Febrile (weil-felix), All Groups (Class I - General Controls, product code GSZ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on November 9, 1976, 19 days after receiving the submission on October 21, 1976.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.3410.
| 510(k) Number | K760881 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 1976 |
| Decision Date | November 09, 1976 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | GSZ — Antigens, Febrile (weil-felix), All Groups |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3410 |