HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER— 510(k) K060318

Clearance details

Applicant

Horiba Abx

Product code

Code CIT

Device class

Class 2

Regulation

21 CFR 862.1100

Advisory panel

Clinical Chemistry

Date received

2006-02-08

Decision date

2006-08-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Montpellier, FR

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• K071211 — COBAS C 111 ANALYZER2007-07-30

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• K081276 — ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H2008-09-12
• K071779 — ABX PENTRA URINE CAL2008-03-05
• K072115 — ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H2007-11-30
• K070146 — ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP2007-10-12

• Z-0632-2013 — 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 colorimetry.Class II·Terminated·Horiba Instruments, Inc dba Horiba Medical·20121010

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060318.