510(k) K993519 ยท JOX Analyzer, Heparin, Automated
RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST
| Applicant | Cardiovascular Diagnostics, Inc., Raleigh NC, US |
| Decision | Substantially Equivalent, Jan 14, 2000 |
| Received | Oct 18, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993519
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.