Cleared Traditional

TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET

K080811 · Roche Diagnostics Corp. · Chemistry
Jun 2008
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K080811 is an FDA 510(k) clearance for the TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET, a Test, Cystatin C (Class II — Special Controls, product code NDY), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on June 20, 2008, 88 days after receiving the submission on March 24, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K080811 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 2008
Decision Date June 20, 2008
Days to Decision 88 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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