Cleared Traditional

TECHNICON TESTPOINT(TM) LIGAND CONTROL

K900717 · Technicon Instruments Corp. · Chemistry
Apr 1990
Decision
71d
Days
Class 1
Risk

About This 510(k) Submission

K900717 is an FDA 510(k) clearance for the TECHNICON TESTPOINT(TM) LIGAND CONTROL, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Technicon Instruments Corp. (New York, US). The FDA issued a Cleared decision on April 26, 1990, 71 days after receiving the submission on February 14, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K900717 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 1990
Decision Date April 26, 1990
Days to Decision 71 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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