510(k) K972260 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
CS-400 COAGULATION ANALYZER SYSTEM (A1208)
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Oct 20, 1997 |
| Received | Jun 17, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972260
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.