RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR— 510(k) K132096

Clearance details

Applicant

Biophor Diagnostics, Inc.

Product code

Code LDJ

Device class

Class 2

Regulation

21 CFR 862.3870

Advisory panel

Clinical Toxicology

Date received

2013-07-08

Decision date

2013-10-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Redwood City, CA, US

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