510(k) K082645 ยท NBC Test, Natriuretic Peptide
DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Sep 22, 2008 |
| Received | Sep 11, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082645
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 24, 2010 | Siemens Healthcare Diagnostics, Inc. The Dimension NTP and LNTP Flex reagent cartridge (N- Terminal Pro- Brain Natriuretic Peptide and N-Terminal Pro brain Natriuretic Peptide (low volume) Terminated |
NBC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.