Cleared Traditional

RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR

K132096 · Biophor Diagnostics, Inc. · Toxicology
Oct 2013
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K132096 is an FDA 510(k) clearance for the RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR, a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ), submitted by Biophor Diagnostics, Inc. (Redwood City, US). The FDA issued a Cleared decision on October 18, 2013, 102 days after receiving the submission on July 8, 2013. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K132096 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 2013
Decision Date October 18, 2013
Days to Decision 102 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LDJ — Enzyme Immunoassay, Cannabinoids
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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