K883083 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 October 25, 1988, 96 days after receiving the submission on July 21, 1988.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3375.
| 510(k) Number | K883083 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 1988 |
| Decision Date | October 25, 1988 |
| Days to Decision | 96 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 |