The following data is part of a premarket notification filed by Syva Co. with the FDA for Microtrakspeciman Id Typing Test Contr.
| Device ID | K841191 |
| 510k Number | K841191 |
| Device Name: | MICROTRAKSPECIMAN ID TYPING TEST CONTR |
| Classification | Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 |
| Applicant | SYVA CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GQN |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-21 |
| Decision Date | 1984-06-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516746144 | K841191 | 000 |