K843657 is an FDA 510(k) clearance for the CYTOMEGALOVIRUS. This device is classified as a Antigen, Cf (including Cf Control), Cytomegalovirus (Class II - Special Controls, product code GQH).
Submitted by Institute Virion , Ltd. (Walker, US). The FDA issued a Cleared decision on September 26, 1985, 374 days after receiving the submission on September 17, 1984.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3175.
| 510(k) Number | K843657 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 1984 |
| Decision Date | September 26, 1985 |
| Days to Decision | 374 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GQH — Antigen, Cf (including Cf Control), Cytomegalovirus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3175 |