510(k) K964609 ยท JBP Activated Whole Blood Clotting Time
ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE
| Applicant | Array Medical, Inc., Bridgewater NJ, US |
| Decision | Substantially Equivalent, Mar 6, 1997 |
| Received | Nov 18, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964609
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.