K912239 is an FDA 510(k) clearance for the VZVSCAN(TM) LATEX AGGUTINATION TEST. This device is classified as a Antigen, Cf, (including Cf Control), Varicella-zoster (Class II - Special Controls, product code GQW).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on June 11, 1991, 21 days after receiving the submission on May 21, 1991.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3900.
| 510(k) Number | K912239 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 1991 |
| Decision Date | June 11, 1991 |
| Days to Decision | 21 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 |