Cleared Traditional

AMY REAGENT

K852001 · Alpkem Corp. · Chemistry
Jun 1985
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K852001 is an FDA 510(k) clearance for the AMY REAGENT, a Catalytic Methods, Amylase (Class II — Special Controls, product code JFJ), submitted by Alpkem Corp. (Clackamas, US). The FDA issued a Cleared decision on June 10, 1985, 34 days after receiving the submission on May 7, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K852001 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 1985
Decision Date June 10, 1985
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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

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