K841434 is an FDA 510(k) clearance for the VARICELLA-ZOSTER(IGG) IFA TEST. This device is classified as a Antigen, Cf, (including Cf Control), Varicella-zoster (Class II - Special Controls, product code GQW).
Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on April 19, 1985, 378 days after receiving the submission on April 6, 1984.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3900.
| 510(k) Number | K841434 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 1984 |
| Decision Date | April 19, 1985 |
| Days to Decision | 378 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GQW — Antigen, Cf, (including Cf Control), Varicella-zoster |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3900 |