510(k) K052789 ยท NBC Test, Natriuretic Peptide
TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200
| Applicant | Biosite Incorporated, San Diego CA, US |
| Decision | Substantially Equivalent, Jan 23, 2006 |
| Received | Oct 3, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052789
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 2, 2014 | Alere San Diego, Inc. Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Numbers: 329599, 331265. The Alere Triage BNP test is intended to be used as an aid Terminated |
NBC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.