ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL— 510(k) K110530

Clearance details

Applicant

HORIBA ABX SAS

Product code

Code CGX

Device class

Class 2

Regulation

21 CFR 862.1225

Advisory panel

Clinical Chemistry

Date received

2011-02-24

Decision date

2012-04-30

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Montpellier, FR

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• Z-1586-2022 — a. ABX PENTRA CREATININE 120CP JAFFE 120/130. Ref: A11A01933. b. Reagent General Chemistry Creatinine Model Number: 1220001933Class II·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·20220525
• Z-1146-2014 — ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers using two measuring principals: absorbance and ion selective electrodes. The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX SAS methods on the ABX PENTRA Clinical Chemistry Analyzer. This calibrator is provided in ten vials of 3 ml.Class II·Terminated·Horiba Instruments, Inc dba Horiba Medical·20140120
• Z-0924-2014 — ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the labeling, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA chemistry analyzers. Each control level is provided in one vial of 10 ml. The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.Class III·Terminated·Horiba Instruments, Inc dba Horiba Medical·20131218

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110530.