510(k) K071224 ยท CDD Radioassay, Vitamin B12
DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Nov 13, 2007 |
| Received | May 2, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071224
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2012 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442)
B12 Flex Reagent Cartridge used with the Dimension Vista System for the in vitro diagnostic test for the quantitative measureme Terminated |
CDD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.