Cleared Traditional

V-TREND DIG ENZYME IMMUNOASSAY TEST KIT

K854972 · V-Tech, Inc. · Chemistry
Jan 1986
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K854972 is an FDA 510(k) clearance for the V-TREND DIG ENZYME IMMUNOASSAY TEST KIT, a Enzyme Immunoassay, Digoxin (Class II — Special Controls, product code KXT), submitted by V-Tech, Inc. (Pomona, US). The FDA issued a Cleared decision on January 22, 1986, 42 days after receiving the submission on December 11, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K854972 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 1985
Decision Date January 22, 1986
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code KXT — Enzyme Immunoassay, Digoxin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3320

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