The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho Brain Thromboplastin Diluent.
| Device ID | K843535 |
| 510k Number | K843535 |
| Device Name: | ORTHO BRAIN THROMBOPLASTIN DILUENT |
| Classification | Test, Time, Prothrombin |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 125 MARK AVENUE Carpinteria , CA 93013 - |
| Contact | Patricia Bonness |
| Correspondent | Patricia Bonness ORTHO DIAGNOSTIC SYSTEMS, INC. 125 MARK AVENUE Carpinteria , CA 93013 - |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-07 |
| Decision Date | 1984-12-12 |