The following data is part of a premarket notification filed by Syva Co. with the FDA for Syva Edms.
Device ID | K912055 |
510k Number | K912055 |
Device Name: | SYVA EDMS |
Classification | Analyzer, Chemistry, Micro, 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 | JJF |
CFR Regulation Number | 862.2170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-05-09 |
Decision Date | 1991-06-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SYVA EDMS 74084851 1704137 Dead/Cancelled |
SYVA DIAGNOSTICS HOLDING COMPANY 1990-08-01 |