Cleared Traditional

A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM

K882587 · A-Kem, Inc. · Chemistry
Aug 1988
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K882587 is an FDA 510(k) clearance for the A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM, a Bromcresol Green Dye-binding, Albumin (Class II — Special Controls, product code CIX), submitted by A-Kem, Inc. (Clifton, US). The FDA issued a Cleared decision on August 8, 1988, 46 days after receiving the submission on June 23, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K882587 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 1988
Decision Date August 08, 1988
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CIX — Bromcresol Green Dye-binding, Albumin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1035

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