510(k) K853328 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS
| Applicant | Ortho Diagnostic Systems, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Nov 5, 1985 |
| Received | Aug 8, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853328
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.