The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Synthafax Aptt Reagent.
Device ID | K955638 |
510k Number | K955638 |
Device Name: | SYNTHAFAX APTT REAGENT |
Classification | Activated Partial Thromboplastin |
Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202 P.O. BOX 350 Raritan, NJ 08869 -0606 |
Contact | Blanche Chien |
Correspondent | Blanche Chien ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202 P.O. BOX 350 Raritan, NJ 08869 -0606 |
Product Code | GFO |
CFR Regulation Number | 864.7925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-12-11 |
Decision Date | 1996-04-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08426950087649 | K955638 | 000 |