K891162 is an FDA 510(k) clearance for the HSV-1 ELISA TEST SYSTEM. This device is classified as a Antisera, Fluorescent, Herpesvirus Hominis 1,2 (Class II - Special Controls, product code GQL).
Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on June 20, 1989, 106 days after receiving the submission on March 6, 1989.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305.
| 510(k) Number | K891162 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 1989 |
| Decision Date | June 20, 1989 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GQL — Antisera, Fluorescent, Herpesvirus Hominis 1,2 |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3305 |