Home / 510(k) Clearances / K201228

510(k) K201228

Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair by Psychemedics Corporation — Product Code JXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2021
Date Received
May 7, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Cocaine
Device Class
Class II
Regulation Number
862.3250
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)
  • 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 JXO

  • K111925 — PSYCHEMEDICS COCAINE EIA (May 1, 2012)
  • K923314 — AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY (August 24, 1992)
  • K921140 — STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIA (August 20, 1992)
  • K915785 — STC DIAGNOSTICS BENZOYLECGONINE EIA (March 11, 1992)
  • K913737 — IL TEST(TM) COCAINE (December 3, 1991)