K850739 is an FDA 510(k) clearance for the AMENDMENT TO LABELING MICROTRAK HSV 1/HSV 2 DIRECT. This device is classified as a Antisera, Fluorescent, Herpesvirus Hominis 1,2 (Class II - Special Controls, product code GQL).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on March 11, 1985, 24 days after receiving the submission on February 15, 1985.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305.
| 510(k) Number | K850739 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 15, 1985 |
| Decision Date | March 11, 1985 |
| Days to Decision | 24 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 |