RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET— 510(k) K142129

Clearance details

Applicant

Biophor Diagnostics, Inc.

Product code

Code DIO

Device class

Class 2

Regulation

21 CFR 862.3250

Advisory panel

Clinical Toxicology

Date received

2014-08-04

Decision date

2015-07-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Redwood City, CA, US

• K213211 — Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System2022-01-27
• K211973 — DRI Cocaine Metabolite Assay2021-09-24
• K191638 — Pointe Scientific Cocaine Metabolite Enzyme Immunoassay2020-03-12
• K181499 — DRI Cocaine Metabolite Assay2018-07-06
• K170293 — Emit II Plus Cocaine Metabolite Assay2017-10-25

• K142293 — Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls2015-09-18
• K141748 — RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET2015-05-20
• K133047 — RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU2014-12-18
• K133642 — RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK2014-01-24
• K132096 — RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR2013-10-18