Cleared Traditional

AXSYM CYCLOSPORINE

K040761 · Abbott Laboratories, Inc. · Chemistry
Apr 2004
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K040761 is an FDA 510(k) clearance for the AXSYM CYCLOSPORINE, a Cyclosporine (Class II — Special Controls, product code MKW), submitted by Abbott Laboratories, Inc. (Abbott Park, US). The FDA issued a Cleared decision on April 30, 2004, 36 days after receiving the submission on March 25, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1235.

Submission Details

510(k) Number K040761 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 2004
Decision Date April 30, 2004
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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