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 |