Cleared Traditional

MASSTRAK IMMUNOSUPPRESSANTS KIT

K063868 · Waters Corporation · Toxicology
May 2007
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K063868 is an FDA 510(k) clearance for the MASSTRAK IMMUNOSUPPRESSANTS KIT, a Enzyme Immunoassay, Tracrolimus (Class II — Special Controls, product code MLM), submitted by Waters Corporation (Beverly, US). The FDA issued a Cleared decision on May 25, 2007, 147 days after receiving the submission on December 29, 2006. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1678.

Submission Details

510(k) Number K063868 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2006
Decision Date May 25, 2007
Days to Decision 147 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code MLM — Enzyme Immunoassay, Tracrolimus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1678

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