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510(k) K142408

FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) by Polymed Therapeutics, Inc. — Product Code LDJ

K142408 is an FDA 510(k) premarket notification submitted by Polymed Therapeutics, Inc. for the device "FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)". The FDA issued a decision of Substantially Equivalent on September 25, 2014. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Polymed Therapeutics, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2014
Date Received
August 28, 2014
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 Polymed Therapeutics, Inc.

  • K132834 — FASTEP S10 HCG SERUM/URINE COMBO TEST (January 9, 2014)
  • K121065 — POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD D (May 24, 2013)
  • K122907 — FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER (March 14, 2013)
  • K112101 — FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS (July 17, 2012)

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)
  • K140546 — HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST (June 6, 2014)
  • K132096 — RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECT (October 18, 2013)

FDA data resources