K811671 is an FDA 510(k) clearance for the CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM. This device is classified as a Antigen, Cf (including Cf Control), Cytomegalovirus (Class II - Special Controls, product code GQH).
Submitted by Zeus Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1981, 93 days after receiving the submission on June 15, 1981.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3175.
| 510(k) Number | K811671 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 1981 |
| Decision Date | September 16, 1981 |
| Days to Decision | 93 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 |