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 |