The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho(tm) Recombiplastin W/ortho Diluent.
Device ID | K925604 |
510k Number | K925604 |
Device Name: | ORTHO(TM) RECOMBIPLASTIN W/ORTHO 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 |
Correspondent | Patrick A Roche 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 | 1992-11-05 |
Decision Date | 1993-03-12 |