Cleared Traditional

V-TREND OC CPK

K854973 · V-Tech, Inc. · Chemistry
Jan 1986
Decision
33d
Days
Class 1
Risk

About This 510(k) Submission

K854973 is an FDA 510(k) clearance for the V-TREND OC CPK, a Enzyme Controls (assayed And Unassayed) (Class I — General Controls, product code JJT), submitted by V-Tech, Inc. (Pomona, US). The FDA issued a Cleared decision on January 13, 1986, 33 days after receiving the submission on December 11, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K854973 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 1985
Decision Date January 13, 1986
Days to Decision 33 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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