510(k) K021162 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Aug 30, 2002 |
| Received | Apr 11, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021162
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.