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510(k) K212952

Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair by Psychemedics Corporation — Product Code LCM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2022
Date Received
September 16, 2021
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 Psychemedics Corporation

  • K210212 — Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair (December 15, 2021)
  • K201326 — Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psycheme (July 27, 2021)
  • K201228 — Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair (June 25, 2021)
  • K192517 — Psychemedics Microplate EIA for Cotinine in Hair (April 22, 2020)
  • K182103 — Psychemedics Microplate EIA for Fentanyl in Hair (April 18, 2019)
  • K163590 — Psychemedics Microplate EIA for Benzodiazepines in Hair (September 15, 2017)

Other clearances for product code LCM

  • 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)
  • K093989 — ORAL FLUID PHENCYCLIDINE (January 25, 2011)