Cleared Traditional

CANTROL CK/MB CONTROL

K855006 · Canyon Diagnostics, Inc. · Chemistry
Jan 1986
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K855006 is an FDA 510(k) clearance for the CANTROL CK/MB CONTROL, a Enzyme Controls (assayed And Unassayed) (Class I — General Controls, product code JJT), submitted by Canyon Diagnostics, Inc. (Anaheim, US). The FDA issued a Cleared decision on January 17, 1986, 35 days after receiving the submission on December 13, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K855006 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 1985
Decision Date January 17, 1986
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJT — Enzyme Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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