K834338 is an FDA 510(k) clearance for the MYCOPLASMA PNEUMONIAE CF ANTIGEN. This device is classified as a Antigens, Cf, All, Mycoplasma Spp. (Class I - General Controls, product code GSB).
Submitted by Hillcrest Biologicals (Walker, US). The FDA issued a Cleared decision on February 27, 1984, 77 days after receiving the submission on December 12, 1983.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3375.
| 510(k) Number | K834338 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 1983 |
| Decision Date | February 27, 1984 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GSB — Antigens, Cf, All, Mycoplasma Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3375 |