510(k) K960749 ยท JBP Activated Whole Blood Clotting Time
HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT
| Applicant | International Technidyne Corp., Edison NJ, US |
| Decision | Substantially Equivalent, Aug 12, 1996 |
| Received | Feb 23, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960749
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2025 | Accriva Diagnostics, Inc. Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System Open, Classified |
JBP | None listed |
| Aug 21, 2009 | International Technidyne Corp. Hemochron Jr. ACT- LR Assay (JACT- LR);
ITC Catalogue/Code Number: JACTLR
45 Cuvettes;
For Performance on the HEMOCHROM Whole Blood Microagulation Systems;
International Technidyne Corp., Edison, NJ 0 Terminated |
JBP | None listed |
| Aug 23, 2005 | International Technidyne Corp. Hemochron Jr. Whole Blood Microcoagulation system Low Range Activated Clotting Time. ACT-LR Cuvettes. In vitro diagnostic use, non-sterile, Packaged in individual foil pouches. 45 foil pouches per Terminated |
JBP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.