510(k) K023582 ยท JBP Activated Whole Blood Clotting Time
I-STAT KAOLIN ACT TEST
| Applicant | I-Stat Corporation, East Windsor NJ, US |
| Decision | Substantially Equivalent, Sep 8, 2003 |
| Received | Oct 24, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023582
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2010 | Abbott Point Of Care Inc. i-STAT ACT Kaolin Cartridges
in vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery. Terminated |
JBP | None listed |
| Feb 23, 2010 | Abbott Point of Care Inc. Abbott i-STAT ACT Kaolin Cartridges.
In vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery. Terminated |
JBP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.