Cleared Traditional

FPR DIGOXIN KIT

K894521 · Colony Laboratories, Inc. · Toxicology
Sep 1989
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K894521 is an FDA 510(k) clearance for the FPR DIGOXIN KIT, a Enzyme Immunoassay, Digoxin (Class II — Special Controls, product code KXT), submitted by Colony Laboratories, Inc. (Washington, US). The FDA issued a Cleared decision on September 25, 1989, 67 days after receiving the submission on July 20, 1989. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K894521 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 1989
Decision Date September 25, 1989
Days to Decision 67 days
Submission Type Traditional
Review Panel Toxicology (TX)
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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