Cleared Traditional

CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER

K072166 · The Binding Site · Chemistry
Jan 2008
Decision
171d
Days
Class 2
Risk

About This 510(k) Submission

K072166 is an FDA 510(k) clearance for the CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER, a Test, Cystatin C (Class II — Special Controls, product code NDY), submitted by The Binding Site (Santa Monica, US). The FDA issued a Cleared decision on January 24, 2008, 171 days after receiving the submission on August 6, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K072166 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 2007
Decision Date January 24, 2008
Days to Decision 171 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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