Cleared Special

Tina-quant Cystatin C Gen.2

K161817 · Roche Diagnostics Operations (Rdo) · Chemistry
Jul 2016
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K161817 is an FDA 510(k) clearance for the Tina-quant Cystatin C Gen.2, a Test, Cystatin C (Class II — Special Controls, product code NDY), submitted by Roche Diagnostics Operations (Rdo) (Indianapolos, US). The FDA issued a Cleared decision on July 27, 2016, 26 days after receiving the submission on July 1, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K161817 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2016
Decision Date July 27, 2016
Days to Decision 26 days
Submission Type Special
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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