510(k) K031739 ยท MMI Immunoassay Method, Troponin Subunit
I-STAT CARDIAC TROPONIN (CTNI) TEST
| Applicant | I-Stat Corporation, East Windsor NJ, US |
| Decision | Substantially Equivalent, Sep 2, 2003 |
| Received | Jun 4, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031739
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2019 | Abbott Point Of Care Inc. i-STAT cTnI cartridge Terminated |
MMI | None listed |
| Jan 24, 2013 | Abbott Point of Care Canada Limited Abbott Point of Care i-Stat cTnI cartridge.
The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plas Terminated |
MMI | None listed |
| Aug 22, 2012 | Abbott Point Of Care Inc. i-STAT cTnI cartridges
Product Usage:
The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac Terminated |
MMI | None listed |
| Aug 9, 2012 | Abbott Point Of Care Inc. i-Stat cTnl cartridges
Abbott Point of Care Inc.
The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma sampl Terminated |
MMI | None listed |
| Nov 10, 2011 | Abbott Point Of Care Inc. i-Stat cTnI cartridges
Is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Terminated |
MMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.