K832132 is an FDA 510(k) clearance for the SERA-TEK MYCOPLASMA ANTIBODY TEST. This device is classified as a Antigens, Cf, All, Mycoplasma Spp. (Class I - General Controls, product code GSB).
Submitted by Miles Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on September 20, 1983, 81 days after receiving the submission on July 1, 1983.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.3375.
| 510(k) Number | K832132 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 1983 |
| Decision Date | September 20, 1983 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | GSB — Antigens, Cf, All, Mycoplasma Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3375 |