K870814 is an FDA 510(k) clearance for the HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2. This device is classified as a Antisera, Fluorescent, Herpesvirus Hominis 1,2 (Class II - Special Controls, product code GQL).
Submitted by Microscan Div. Baxter Healthcare Corp. (West Sacramento, US). The FDA issued a Cleared decision on June 4, 1987, 93 days after receiving the submission on March 3, 1987.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305.
| 510(k) Number | K870814 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 1987 |
| Decision Date | June 04, 1987 |
| Days to Decision | 93 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 |