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510(k) K182103

Psychemedics Microplate EIA for Fentanyl in Hair by Psychemedics Corporation — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2019
Date Received
August 3, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

Other clearances by Psychemedics Corporation

  • K212952 — Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair (April 18, 2022)
  • 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)
  • K163590 — Psychemedics Microplate EIA for Benzodiazepines in Hair (September 15, 2017)

Other clearances for product code DJG

  • K252684 — Labcorp Fentanyl Urine Visual Test (January 29, 2026)
  • K250741 — Evidence MultiSTAT DOA Urine MultiPlex (January 23, 2026)
  • K253082 — LZI Buprenorphine II Enzyme Immunoassay (January 16, 2026)
  • K252520 — SEFRIA™ Hydrocodone Oral Fluid (September 11, 2025)
  • K251972 — Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative (August 15, 2025)
  • K251634 — LZI Fentanyl III Enzyme Immunoassay (June 18, 2025)
  • K240124 — BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader (June 14, 2024)
  • K240698 — Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard (May 10, 2024)
  • K231904 — Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard (March 8, 2024)
  • K232228 — Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug (February 23, 2024)