510(k) K914188 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM
| Applicant | Ortho Diagnostic Systems, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Aug 26, 1992 |
| Received | Sep 18, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914188
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.