Cleared Traditional

ACE AMYLASE REAGENT

K951548 · Schiapparelli Biosystems, Inc. · Chemistry
May 1995
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K951548 is an FDA 510(k) clearance for the ACE AMYLASE REAGENT, a Catalytic Methods, Amylase (Class II — Special Controls, product code JFJ), submitted by Schiapparelli Biosystems, Inc. (Columbia, US). The FDA issued a Cleared decision on May 15, 1995, 41 days after receiving the submission on April 4, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K951548 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 1995
Decision Date May 15, 1995
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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