K862630 is an FDA 510(k) clearance for the MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM. This device is classified as a Antisera, All Mycoplasma Spp. (Class I - General Controls, product code GSA).
Submitted by Medical Diagnostic Technologies, Inc. (Augusta, US). The FDA issued a Cleared decision on September 3, 1986, 55 days after receiving the submission on July 10, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3375.
| 510(k) Number | K862630 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 1986 |
| Decision Date | September 03, 1986 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GSA — Antisera, All Mycoplasma Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3375 |