Cleared Special

AMYLASE LIQUID REAGENT, MODEL A532-200

K040920 · Teco Diagnostics · Chemistry
May 2004
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K040920 is an FDA 510(k) clearance for the AMYLASE LIQUID REAGENT, MODEL A532-200, a Catalytic Methods, Amylase (Class II — Special Controls, product code JFJ), submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on May 10, 2004, 32 days after receiving the submission on April 8, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K040920 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 2004
Decision Date May 10, 2004
Days to Decision 32 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JFJ — Catalytic Methods, Amylase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1070

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