Submission Details
| 510(k) Number | K942743 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 10, 1994 |
| Decision Date | December 15, 1994 |
| Days to Decision | 188 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT
Dec 1994
Decision
188d
Days
Class 2
Risk
About This 510(k) Submission
K942743 is an FDA 510(k) clearance for the VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT, a Antigen, Cf, (including Cf Control), Varicella-zoster (Class II — Special Controls, product code GQW), submitted by Viro Research, Inc. (Rockford, US). The FDA issued a Cleared decision on December 15, 1994, 188 days after receiving the submission on June 10, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3900.
Device Classification
| Product Code | GQW — Antigen, Cf, (including Cf Control), Varicella-zoster |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.3900 |
Manufacturer
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