K872700 is an FDA 510(k) clearance for the YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN. This device is classified as a Antigen, Cf, Psittacosis (chlamydia Group) (Class I - General Controls, product code GPW).
Submitted by Sita, Inc. (Allentown, US). The FDA issued a Cleared decision on October 15, 1987, 100 days after receiving the submission on July 7, 1987.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3120.
| 510(k) Number | K872700 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 1987 |
| Decision Date | October 15, 1987 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GPW — Antigen, Cf, Psittacosis (chlamydia Group) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3120 |