The following data is part of a premarket notification filed by Syva Co. with the FDA for Microtak Plus.
Device ID | K913840 |
510k Number | K913840 |
Device Name: | MICROTAK PLUS |
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 | 1991-08-26 |
Decision Date | 1991-09-30 |