ClearanceBrief
Company ยท US

Biophor Diagnostics, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2015. Name variants (Inc, Corp, punctuation) are merged.

7510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
LAFGas Chromatography, Methamphetamine2
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites1
DJGEnzyme Immunoassay, Opiates1
DKZEnzyme Immunoassay, Amphetamine1
LCMEnzyme Immunoassay, Phencyclidine1
LDJEnzyme Immunoassay, Cannabinoids1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Sep 18, 2015K142293Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid M
Biophor Diagnostics, Inc.
LAF
Jul 24, 2015K142129RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTRO
Biophor Diagnostics, Inc.
DIO
May 20, 2015K141748RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHET
Biophor Diagnostics, Inc.
DKZ
Dec 18, 2014K133047RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU
Biophor Diagnostics, Inc.
LAF
Jan 24, 2014K133642RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK
Biophor Diagnostics, Inc.
DJG
Oct 18, 2013K132096RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR
Biophor Diagnostics, Inc.
LDJ
Apr 25, 2013K122703RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR
Biophor Diagnostics, Inc.
LCM

Latest recalls

DateFirm and productCodeLinked 510(k)
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