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510(k) K132096

RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR by Biophor Diagnostics, Inc. — Product Code LDJ

K132096 is an FDA 510(k) premarket notification submitted by Biophor Diagnostics, Inc. for the device "RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR". The FDA issued a decision of Substantially Equivalent on October 18, 2013. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Biophor Diagnostics, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2013
Date Received
July 8, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Cannabinoids
Device Class
Class II
Regulation Number
862.3870
Review Panel
TX
Submission Type

Other clearances by Biophor Diagnostics, Inc.

  • K142293 — Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methampheta (September 18, 2015)
  • K142129 — RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR (July 24, 2015)
  • K141748 — RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CAL (May 20, 2015)
  • K133047 — RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET (December 18, 2014)
  • K133642 — RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTRO (January 24, 2014)
  • K122703 — RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAP (April 25, 2013)

Other clearances for product code LDJ

  • K232732 — Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapi (January 17, 2024)
  • K232604 — LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test (January 10, 2024)
  • K223162 — Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test C (March 17, 2023)
  • K192515 — BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY (October 11, 2019)
  • K153741 — CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test (March 18, 2016)
  • K152643 — EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Te (November 2, 2015)
  • K151203 — Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibr (June 5, 2015)
  • K141320 — LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Cali (May 28, 2015)
  • K142408 — FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep (September 25, 2014)
  • K140546 — HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST (June 6, 2014)

FDA data resources