The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho Abnormal Coagulation Level I/ii.
| Device ID | K832225 |
| 510k Number | K832225 |
| Device Name: | ORTHO ABNORMAL COAGULATION LEVEL I/II |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 125 MARK AVENUE Carpinteria , CA 93013 - |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-08 |
| Decision Date | 1983-08-12 |