Cleared Traditional

WAKO(TM) AUTOKIT AMYLASE

K883059 · Wako Chemicals USA, Inc. · Chemistry
Aug 1988
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K883059 is an FDA 510(k) clearance for the WAKO(TM) AUTOKIT AMYLASE, a Amyloclastic, Amylase (Class II — Special Controls, product code CJA), submitted by Wako Chemicals USA, Inc. (Dallas, US). The FDA issued a Cleared decision on August 30, 1988, 42 days after receiving the submission on July 19, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K883059 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 1988
Decision Date August 30, 1988
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CJA — Amyloclastic, Amylase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1070

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