510(k) K992571 ยท JBP Activated Whole Blood Clotting Time
I-STAT SYSTEM
| Applicant | I-Stat Corp., East Windsor NJ, US |
| Decision | Substantially Equivalent, Feb 10, 2000 |
| Received | Aug 2, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992571
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 16, 2011 | Abbott Point Of Care Inc. Celite ACT Cartridge
Cartridge is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis, and for monitoring anticoagulation therapy in patients und Terminated |
JBP | None listed |
| Nov 17, 2010 | Abbott Point Of Care Inc. i-STAT ACT Celite Cartridges
in vitro diagnostic test used to monitor moderate and high-level heparin therapy through analysis of arterial and venous whole blood samples. Terminated |
JBP | None listed |
| Feb 23, 2010 | Abbott Point of Care Inc. Abbott i-STAT ACT Celite Cartridges.
In vitro diagnostic test used to monitor moderate and high-level heparin therapy through analysis of arterial and venous whole blood samples. Terminated |
JBP | None listed |
| Jun 21, 2005 | Abbott Laboratories i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test. Terminated |
JBP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.