Cleared Traditional

AMYLASE

K980013 · Ac Biochemicals, Inc. · Chemistry
Feb 1998
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K980013 is an FDA 510(k) clearance for the AMYLASE, a Saccharogenic, Amylase (Class II — Special Controls, product code CIJ), submitted by Ac Biochemicals, Inc. (Irvine, US). The FDA issued a Cleared decision on February 4, 1998, 33 days after receiving the submission on January 2, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K980013 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 1998
Decision Date February 04, 1998
Days to Decision 33 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CIJ — Saccharogenic, Amylase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1070

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