Medical Device Manufacturer · US , Redwood City , CA

Biophor Diagnostics, Inc.

7 submissions · 7 cleared · Since 2013
7
Total
7
Cleared
0
Denied

Biophor Diagnostics, Inc. — FDA 510(k) Submissions

Biophor Diagnostics, Inc. has submitted 7 FDA 510(k) premarket notifications since 2013, of which 7 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Gas Chromatography, Methamphetamine, Enzyme Immunoassay, Phencyclidine, Enzyme Immunoassay, Cannabinoids, Enzyme Immunoassay, Opiates, Enzyme Immunoassay, Amphetamine . Use the specialty filter in the sidebar to narrow results.

7 devices
1–7 of 7
Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls
K142293 · LAF Gas Chromatography,... · Toxicology
Sep 2015 396d
RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET
K142129 · DIO Enzyme Immunoassay,... · Toxicology
Jul 2015 354d
RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET
K141748 · DKZ Enzyme Immunoassay,... · Toxicology
May 2015 324d
RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU
K133047 · LAF Gas Chromatography,... · Chemistry
Dec 2014 447d
RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK
K133642 · DJG Enzyme Immunoassay, Opiates · Toxicology
Jan 2014 58d
RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR
K132096 · LDJ Enzyme Immunoassay,... · Toxicology
Oct 2013 102d
RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR
K122703 · LCM Enzyme Immunoassay,... · Toxicology
Apr 2013 233d
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