510(k) K060318 ยท CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
| Applicant | Horiba Abx, Montpellier, FR |
| Decision | Substantially Equivalent, Aug 8, 2006 |
| Received | Feb 8, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060318
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 3, 2013 | Horiba Instruments, Inc dba Horiba Medical ABX PENTRA AST CP, Part Number: A11A01629.
The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by col Terminated |
CIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.