Cleared Traditional

INTERSECT SYSTEMS DIRECT AMYLASE REAGENT

K932888 · Intersect Systems, Inc. · Chemistry
Jan 1994
Decision
231d
Days
Class 2
Risk

About This 510(k) Submission

K932888 is an FDA 510(k) clearance for the INTERSECT SYSTEMS DIRECT AMYLASE REAGENT, a Catalytic Methods, Amylase (Class II — Special Controls, product code JFJ), submitted by Intersect Systems, Inc. (Longview, US). The FDA issued a Cleared decision on January 31, 1994, 231 days after receiving the submission on June 14, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K932888 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 1993
Decision Date January 31, 1994
Days to Decision 231 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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