The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho Recombiplastin Ii W/ortho Recombiplastin Ii Diluent.
| Device ID | K935748 |
| 510k Number | K935748 |
| Device Name: | ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT |
| Classification | Test, Time, Prothrombin |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202 P.O. BOX 350 Raritan, NJ 08869 -0606 |
| Contact | Patrick A Roche, Ph.d |
| Correspondent | Patrick A Roche, Ph.d ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202 P.O. BOX 350 Raritan, NJ 08869 -0606 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-01 |
| Decision Date | 1995-04-26 |