510(k) K061020 ยท CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt
DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, May 10, 2006 |
| Received | Apr 13, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061020
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2017 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Aspartate Aminotransferase (AST) assay; (Product Number: K2014/10445148) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) Terminated |
CIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.