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510(k) K080381

QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA by Quest Diagnostics, Inc. — Product Code LAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2008
Date Received
February 13, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas Chromatography, Methamphetamine
Device Class
Class II
Regulation Number
862.3610
Review Panel
TX
Submission Type

Other clearances by Quest Diagnostics, Inc.

  • 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)
  • K040257 — QUEST DIAGNOSTICS HAIRCHECK-DT (THC) (June 14, 2004)
  • K023626 — AML HAIRCHECK-DT (COCAINE) (September 29, 2003)

Other clearances for product code LAF

  • K203647 — SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay (December 22, 2021)
  • K210212 — Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair (December 15, 2021)
  • K201442 — Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus (July 31, 2020)
  • K170222 — Rapid Tox Cup II (August 15, 2017)
  • K153693 — Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Cal (March 18, 2016)
  • K142293 — Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methampheta (September 18, 2015)
  • K150096 — Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclid (March 4, 2015)
  • K150162 — First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (February 26, 2015)
  • K133047 — RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET (December 18, 2014)
  • K131652 — LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS (March 21, 2014)