510(k) K053597 ยท NBC Test, Natriuretic Peptide
I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)
| Applicant | I-Stat Corporation, East Windsor NJ, US |
| Decision | Substantially Equivalent, Jul 21, 2006 |
| Received | Dec 23, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053597
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2012 | Abbott Point Of Care Inc. i-Stat BNP cartridges
Abbott Point of Care Inc.
The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement of B-type Natriuretic Peptide (BNP) in whole blood or plasma sampl Terminated |
NBC | None listed |
| Nov 3, 2010 | Abbott Point Of Care Inc. i-STAT BNP 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.