Cleared Traditional

K141748 - RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET
(FDA 510(k) Clearance)

K141748 · Biophor Diagnostics, Inc. · Toxicology

May 2015

Decision

324d

Days

Class 2

Risk

K141748 is an FDA 510(k) clearance for the RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET. This device is classified as a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ).

Submitted by Biophor Diagnostics, Inc. (Redwood City, US). The FDA issued a Cleared decision on May 20, 2015, 324 days after receiving the submission on June 30, 2014.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number	K141748 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2014
Decision Date	May 20, 2015
Days to Decision	324 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF