K964872 is an FDA 510(k) clearance for the VZV ANTIGEN CONTROL SLIDES. This device is classified as a Antigen, Cf, (including Cf Control), Varicella-zoster (Class II - Special Controls, product code GQW).
Submitted by Viral Antigens, Inc. (Memphis, US). The FDA issued a Cleared decision on March 18, 1997, 103 days after receiving the submission on December 5, 1996.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3900.
| 510(k) Number | K964872 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 1996 |
| Decision Date | March 18, 1997 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | GQW — Antigen, Cf, (including Cf Control), Varicella-zoster |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3900 |