Cleared Traditional

COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET

K141143 · Roche Diagnostics · Chemistry
Jul 2014
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K141143 is an FDA 510(k) clearance for the COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET, a Test, Cystatin C (Class II — Special Controls, product code NDY), submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on July 17, 2014, 76 days after receiving the submission on May 2, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K141143 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2014
Decision Date July 17, 2014
Days to Decision 76 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code NDY — Test, Cystatin C
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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