Cleared Traditional

ARCHITECT CYCLOSPORINE

K080751 · Fujirebio Diagnostics,Inc. · Toxicology
Sep 2008
Decision
177d
Days
Class 2
Risk

About This 510(k) Submission

K080751 is an FDA 510(k) clearance for the ARCHITECT CYCLOSPORINE, a Cyclosporine (Class II — Special Controls, product code MKW), submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on September 11, 2008, 177 days after receiving the submission on March 18, 2008. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1235.

Submission Details

510(k) Number K080751 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2008
Decision Date September 11, 2008
Days to Decision 177 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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