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510(k) K040257

QUEST DIAGNOSTICS HAIRCHECK-DT (THC) by Quest Diagnostics, Inc. — Product Code LDJ

K040257 is an FDA 510(k) premarket notification submitted by Quest Diagnostics, Inc. for the device "QUEST DIAGNOSTICS HAIRCHECK-DT (THC)". The FDA issued a decision of Substantially Equivalent on June 14, 2004. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Quest Diagnostics, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2004
Date Received
February 4, 2004
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 Quest Diagnostics, Inc.

  • K080381 — QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA (June 25, 2008)
  • K062929 — QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA (December 18, 2006)
  • K051161 — QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES) (November 22, 2005)
  • K042726 — QUEST DIAGNOSTICS HAIRCHECK-DT (PCP (July 28, 2005)
  • K042725 — QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES) (July 6, 2005)
  • K023626 — AML HAIRCHECK-DT (COCAINE) (September 29, 2003)

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