510(k) K013078 ยท JBP Activated Whole Blood Clotting Time
ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Jan 10, 2002 |
| Received | Sep 14, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013078
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 9, 2020 | Helena Laboratories, Corp. K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM. Open, Classified |
JPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.