Cleared Traditional

GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR

K080662 · Genzyme Corporation · Chemistry
May 2008
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K080662 is an FDA 510(k) clearance for the GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR, a Test, Cystatin C (Class II — Special Controls, product code NDY), submitted by Genzyme Corporation (Framingham, US). The FDA issued a Cleared decision on May 15, 2008, 66 days after receiving the submission on March 10, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K080662 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 2008
Decision Date May 15, 2008
Days to Decision 66 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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