The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Quantitative Fibrinogen Assay.
| Device ID | K963902 |
| 510k Number | K963902 |
| Device Name: | QUANTITATIVE FIBRINOGEN ASSAY |
| Classification | Test, Fibrinogen |
| 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 | GIS |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-27 |
| Decision Date | 1996-11-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950573500 | K963902 | 000 |
| 08426950573494 | K963902 | 000 |