Cleared Traditional

Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls

K142293 · Biophor Diagnostics, Inc. · Toxicology
Sep 2015
Decision
396d
Days
Class 2
Risk

About This 510(k) Submission

K142293 is an FDA 510(k) clearance for the Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls, a Gas Chromatography, Methamphetamine (Class II — Special Controls, product code LAF), submitted by Biophor Diagnostics, Inc. (Redwood City, US). The FDA issued a Cleared decision on September 18, 2015, 396 days after receiving the submission on August 18, 2014. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3610.

Submission Details

510(k) Number K142293 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 2014
Decision Date September 18, 2015
Days to Decision 396 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LAF — Gas Chromatography, Methamphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3610

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