510(k) K051433 ยท MYT Biosensor, Immunoassay, Cpk Or Isoenzymes
I-STAT CREATINE KINASE MB (CK-MB)
| Applicant | I-Stat Corporation, East Windsor NJ, US |
| Decision | Substantially Equivalent, Dec 15, 2005 |
| Received | Jun 1, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051433
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2019 | Abbott Point Of Care Inc. i-STAT cTnI cartridge Terminated |
MMI | None listed |
| Aug 9, 2012 | Abbott Point Of Care Inc. i-Stat CK-MP cartridges
Abbott Point of Care Inc.
The i-Stat CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. C Terminated |
MYT | None listed |
| Nov 3, 2010 | Abbott Point Of Care Inc. i-STAT cTnl cartridge
Abbott Point of Care,
Princeton, NJ 08540 Terminated |
CHL | None listed |
| Nov 3, 2010 | Abbott Point Of Care Inc. i-STAT CK-MB cartridge
Abbott Point of Care,
Princeton, NJ 08540 Terminated |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.