Cleared Traditional

JAS AMYLASE LIQUID REAGENT

K020282 · Jas Diagnostics, Inc. · Chemistry
Feb 2002
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K020282 is an FDA 510(k) clearance for the JAS AMYLASE LIQUID REAGENT, a Catalytic Methods, Amylase (Class II — Special Controls, product code JFJ), submitted by Jas Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on February 28, 2002, 31 days after receiving the submission on January 28, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K020282 FDA.gov
FDA Decision Cleared SESE
Date Received January 28, 2002
Decision Date February 28, 2002
Days to Decision 31 days
Submission Type Traditional
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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