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510(k) K042726

QUEST DIAGNOSTICS HAIRCHECK-DT (PCP by Quest Diagnostics, Inc. — Product Code LCM

K042726 is an FDA 510(k) premarket notification submitted by Quest Diagnostics, Inc. for the device "QUEST DIAGNOSTICS HAIRCHECK-DT (PCP". The FDA issued a decision of Substantially Equivalent on July 28, 2005. The device falls under product code LCM (Enzyme Immunoassay, Phencyclidine), a Class U device. Quest Diagnostics, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2005
Date Received
October 1, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Phencyclidine
Device Class
Class U
Regulation Number
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)
  • 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 LCM

  • K212952 — Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair (April 18, 2022)
  • K203489 — SEFRIA PCP Oral Fluid Enzyme Immunoassay (April 20, 2021)
  • K181135 — Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay (January 24, 2019)
  • K163220 — Atellica CH Phencyclidine (Pcp) (April 6, 2017)
  • K152176 — Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (September 4, 2015)
  • K142044 — CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE (August 25, 2014)
  • K131181 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE (June 25, 2013)
  • K122703 — RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAP (April 25, 2013)
  • K111928 — PSYCHEMEDICS PHENCYCLIDINE EIA (May 1, 2012)
  • K101746 — THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY (April 8, 2011)

FDA data resources