510(k) K904003 ยท KFF Assay, Heparin
HEMOCHRON(R) HEPARIN RESPONSE TEST
| Applicant | Intensive Technology, Inc., Edison NJ, US |
| Decision | Substantially Equivalent, Nov 29, 1990 |
| Received | Aug 29, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904003
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2010 | International Technidyne Corp. RQCHRT HRT Control Level 1 & 2;
Whole Blood controls for use with Hemochron Kaolin and Celite HRT Test Tubes.
20 vials Whole Blood - 2.0mL; dried
20 vials Diluent - 4.0 mL
The Hemochron HRT Whole Blo Terminated |
KFF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.