Cleared Traditional

AMYLASE REAGENT KIT FOR ASTRA SYSTEMS

K884226 · A-Kem, Inc. · Chemistry
Dec 1988
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K884226 is an FDA 510(k) clearance for the AMYLASE REAGENT KIT FOR ASTRA SYSTEMS, a Amyloclastic, Amylase (Class II — Special Controls, product code CJA), submitted by A-Kem, Inc. (Clifton, US). The FDA issued a Cleared decision on December 9, 1988, 64 days after receiving the submission on October 6, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K884226 FDA.gov
FDA Decision Cleared SESE
Date Received October 06, 1988
Decision Date December 09, 1988
Days to Decision 64 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