The following data is part of a premarket notification filed by Syva Co. with the FDA for Microtrak Manager.
| Device ID | K912959 |
| 510k Number | K912959 |
| Device Name: | MICROTRAK MANAGER |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
| Contact | Paul L.rogers |
| Correspondent | Paul L.rogers SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-08 |
| Decision Date | 1991-07-26 |