The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Koagulab 40-a Automated Coagulation Sys.
Device ID | K823131 |
510k Number | K823131 |
Device Name: | KOAGULAB 40-A AUTOMATED COAGULATION SYS |
Classification | Instrument, Coagulation |
Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 125 MARK AVENUE Carpinteria , CA 93013 - |
Product Code | KQG |
CFR Regulation Number | 864.5400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-10-25 |
Decision Date | 1982-12-09 |