510(k) K860122 ยท JBP Activated Whole Blood Clotting Time
HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME
| Applicant | Medical Device Consultants, Inc., North Attleboro MA, US |
| Decision | Substantially Equivalent, Apr 4, 1986 |
| Received | Jan 14, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860122
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2025 | Medtronic Perfusion Systems Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03 Open, Classified |
JBP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.