The following data is part of a premarket notification filed by Syva Co. with the FDA for Microtrak Hsv 1/hsv 2 Culture Identi./typing Test.
| Device ID | K880157 |
| 510k Number | K880157 |
| Device Name: | MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST |
| Classification | Antigen, Cf (including Cf Control), Rubella |
| Applicant | SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
| Contact | Rogers, Jr. |
| Correspondent | Rogers, Jr. SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
| Product Code | GON |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-13 |
| Decision Date | 1988-02-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516746007 | K880157 | 000 |