K841191 is an FDA 510(k) clearance for the MICROTRAKSPECIMAN ID TYPING TEST CONTR. This device is classified as a Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 (Class II - Special Controls, product code GQN).
Submitted by Syva Co. (Walker, US). The FDA issued a Cleared decision on June 19, 1984, 90 days after receiving the submission on March 21, 1984.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305.
| 510(k) Number | K841191 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 1984 |
| Decision Date | June 19, 1984 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GQN — Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3305 |