Cleared Traditional

HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER

K080384 · The Binding Site, Ltd. · Chemistry
Jun 2008
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K080384 is an FDA 510(k) clearance for the HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER, a Test, Cystatin C (Class II — Special Controls, product code NDY), submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on June 6, 2008, 114 days after receiving the submission on February 13, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K080384 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2008
Decision Date June 06, 2008
Days to Decision 114 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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