Cleared Traditional

ATAC PAK ALP REAGENT KIT

K002285 · Elan Diagnostics · Chemistry
Sep 2000
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K002285 is an FDA 510(k) clearance for the ATAC PAK ALP REAGENT KIT, a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJE), submitted by Elan Diagnostics (Brea, US). The FDA issued a Cleared decision on September 26, 2000, 62 days after receiving the submission on July 26, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K002285 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2000
Decision Date September 26, 2000
Days to Decision 62 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CJE — Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1050

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