510(k) K001679 ยท CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jun 28, 2000 |
| Received | Jun 1, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001679
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products AST Slides packaged as 300 slides/pack catalog number 8433815
VITROS AST Slides quantitatively measure aspartate aminotransferase (AST) activity in serum and plasma using VIT Terminated |
CIT | None listed |
| Mar 22, 2012 | Ortho-Clinical Diagnostics VITROS Chemistry Products --- ALT Slides --- [REF] 165 5281 --- [Mfg Symbol] Ortho-Clinical Diagnostics, Inc., Rochester, NY USA. The recalled device is the calibration disk contained within the VITRO Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.