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510(k) K192517

Psychemedics Microplate EIA for Cotinine in Hair by Psychemedics Corporation — Product Code MKU

K192517 is an FDA 510(k) premarket notification submitted by Psychemedics Corporation for the device "Psychemedics Microplate EIA for Cotinine in Hair". The FDA issued a decision of Substantially Equivalent on April 22, 2020. The device falls under product code MKU (Enzyme Immunoassay, Nicotine And Nicotine Metabolites), a Class I device regulated under 21 CFR 862.3220. Psychemedics Corporation has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2020
Date Received
September 13, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Nicotine And Nicotine Metabolites
Device Class
Class I
Regulation Number
862.3220
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)
  • 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 MKU

  • K192299 — LZI Cotinine II Enzyme Immunoassay (November 21, 2019)
  • K062565 — STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE (February 20, 2007)
  • K021944 — COZART EIA COTININE URINE KIT (May 14, 2003)
  • K974534 — MICRO-PLATE COTININE EIA (May 18, 1998)
  • K974234 — MICRO-PLATE COTININE EIA (May 14, 1998)
  • K972481 — AUTO-LYTE COTININE EIA (October 21, 1997)

FDA data resources