The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Koagulab* 32-s Coagulation System.
| Device ID | K885035 |
| 510k Number | K885035 |
| Device Name: | KOAGULAB* 32-S COAGULATION SYSTEM |
| Classification | Instrument, Coagulation, Automated |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202 P.O. BOX 350 Raritan, NJ 08869 -0606 |
| Contact | Patricia Bonness |
| Correspondent | Patricia Bonness ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202 P.O. BOX 350 Raritan, NJ 08869 -0606 |
| Product Code | GKP |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-05 |
| Decision Date | 1989-02-03 |