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510(k) K010921

ADVANTAGE MARIJUANA (THC) HOME DRUG TEST by Advantage Diagnostics Corp. — Product Code LDJ

K010921 is an FDA 510(k) premarket notification submitted by Advantage Diagnostics Corp. for the device "ADVANTAGE MARIJUANA (THC) HOME DRUG TEST". The FDA issued a decision of Substantially Equivalent on June 25, 2001. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Advantage Diagnostics Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2001
Date Received
March 27, 2001
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 Advantage Diagnostics Corp.

  • K023712 — ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST (January 31, 2003)
  • K013778 — PEACE OF MIND HOME DRUG TEST (February 7, 2002)
  • K011962 — ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST (August 9, 2001)
  • K003708 — ADVANTAGE THC/COCAINE TEST (January 22, 2001)
  • K001567 — ADVANTAGE THC TEST (June 19, 2000)
  • K994227 — ADVANTAGE HCG TEST (URINE/SERUM) (February 3, 2000)
  • K991883 — REDI-TEST OPIATES (September 15, 1999)
  • K903416 — CANNULA, SURGICAL (November 23, 1990)
  • K881369 — ADVANCE DIAGNOSTICS DISPOSABLE EYECUP (May 13, 1988)

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