Cleared Traditional

COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR

K141928 · Roche Diagnostics Operations (Rdo) · Chemistry
Nov 2014
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K141928 is an FDA 510(k) clearance for the COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR, a Calibrators, Drug Mixture (Class II — Special Controls, product code DKB), submitted by Roche Diagnostics Operations (Rdo) (Indianapolos, US). The FDA issued a Cleared decision on November 25, 2014, 132 days after receiving the submission on July 16, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K141928 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2014
Decision Date November 25, 2014
Days to Decision 132 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DKB — Calibrators, Drug Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3200

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