Cleared Traditional

CANTROL ELECTROPHORESIS CONTROL

K854931 · Canyon Diagnostics, Inc. · Chemistry
Jan 1986
Decision
38d
Days
Class 1
Risk

About This 510(k) Submission

K854931 is an FDA 510(k) clearance for the CANTROL ELECTROPHORESIS CONTROL, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Canyon Diagnostics, Inc. (Anaheim, US). The FDA issued a Cleared decision on January 17, 1986, 38 days after receiving the submission on December 10, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K854931 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 1985
Decision Date January 17, 1986
Days to Decision 38 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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