Cleared Traditional

CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM

K884227 · A-Kem, Inc. · Chemistry
Dec 1988
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K884227 is an FDA 510(k) clearance for the CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), 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 862.1150.

Submission Details

510(k) Number K884227 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 JIX — Calibrator, Multi-analyte Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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