K843654 is an FDA 510(k) clearance for the CHLAMYDIA. This device is classified as a Antigen, Cf, Psittacosis (chlamydia Group) (Class I - General Controls, product code GPW).
Submitted by Institute Virion , Ltd. (Mchenry, US). The FDA issued a Cleared decision on August 8, 1985, 325 days after receiving the submission on September 17, 1984.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3120.
| 510(k) Number | K843654 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 1984 |
| Decision Date | August 08, 1985 |
| Days to Decision | 325 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 |