Cleared Traditional

CANTROL URINE DIPSTICK CONTROL TWO LEVELS

K853603 · Canyon Diagnostics, Inc. · Chemistry
Oct 1985
Decision
41d
Days
Class 1
Risk

About This 510(k) Submission

K853603 is an FDA 510(k) clearance for the CANTROL URINE DIPSTICK CONTROL TWO LEVELS, a Urinalysis Controls (assayed And Unassayed) (Class I — General Controls, product code JJW), submitted by Canyon Diagnostics, Inc. (Anaheim, US). The FDA issued a Cleared decision on October 8, 1985, 41 days after receiving the submission on August 28, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K853603 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 1985
Decision Date October 08, 1985
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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

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