Cleared Traditional

CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108

K052017 · Dade Behring, Inc. · Toxicology
Sep 2005
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K052017 is an FDA 510(k) clearance for the CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108, a Cyclosporine (Class II — Special Controls, product code MKW), submitted by Dade Behring, Inc. (P.O. Box 6101, Newark, US). The FDA issued a Cleared decision on September 1, 2005, 37 days after receiving the submission on July 26, 2005. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1235.

Submission Details

510(k) Number K052017 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2005
Decision Date September 01, 2005
Days to Decision 37 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code MKW — Cyclosporine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1235

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