Cleared Traditional

RADIOASSAY CONTROLS 19,20,21,33,34 & 35 (QAS.109)

K890414 · Amersham Corp. · Chemistry
Mar 1989
Decision
50d
Days
Class 1
Risk

About This 510(k) Submission

K890414 is an FDA 510(k) clearance for the RADIOASSAY CONTROLS 19,20,21,33,34 & 35 (QAS.109), a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on March 15, 1989, 50 days after receiving the submission on January 24, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K890414 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 1989
Decision Date March 15, 1989
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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