510(k) K031873 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET
| Applicant | I-Stat Corporation, East Windsor NJ, US |
| Decision | Substantially Equivalent, Oct 7, 2003 |
| Received | Jun 17, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031873
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2011 | Abbott Point Of Care Inc. Cardiac Marker Control Level 1, List Number 136601-06F12-02; Cardiac Marker Control Level 2, List number 136602/06F13-02; and Cardiac Marker Control Level 3, List number 136603/06F14-02.
Used to ver Terminated |
JJX | None listed |
| Apr 1, 2011 | Abbott Point Of Care Inc. Cardiac Marker Control Calibration Verification Set, List number 136604/06F15-02.
Used to verify the accuracy of results over the measurement range of the i-STAT cTnI test. Terminated |
JJX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.