Vitros Chemistry Products Thc Reagent, Calibrator Kit 30, Fs Calibrator 1, and Dat Performance Verifiers I, II, III, IV

• • Terminated Z-1805-2014 FDA Class II ·initiated 12 May 2014 ·on shared 510(k) K063164

  Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). The validation process was not complete prior to calibrator value assignment for VITROS (R) Chemistry Products hsCRP Reagent (Product Code 6801739), Generation (GEN) 28.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K063164 ↗

FDA Product Code

LDJ

Device Class

Class II

Regulation

21 CFR Part 862.3870

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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