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510(k) K111927

PSYCHEMEDICS METHAMPHETAMINE EIA by Psychemedics Corp. — Product Code LAF

K111927 is an FDA 510(k) premarket notification submitted by Psychemedics Corp. for the device "PSYCHEMEDICS METHAMPHETAMINE EIA". The FDA issued a decision of Substantially Equivalent on May 1, 2012. The device falls under product code LAF (Gas Chromatography, Methamphetamine), a Class II device regulated under 21 CFR 862.3610. Psychemedics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2012
Date Received
July 6, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas Chromatography, Methamphetamine
Device Class
Class II
Regulation Number
862.3610
Review Panel
TX
Submission Type

Other clearances by Psychemedics Corp.

  • K130811 — PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE (May 2, 2013)
  • K123799 — PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR (February 8, 2013)
  • K111926 — PSYCHEMEDICS OPIATES EIA (May 1, 2012)
  • K111925 — PSYCHEMEDICS COCAINE EIA (May 1, 2012)
  • K111929 — PSYCHEMEDICS CANNABINOIDS EIA (May 1, 2012)
  • K111928 — PSYCHEMEDICS PHENCYCLIDINE EIA (May 1, 2012)
  • K011426 — PSYCHEMEDICS RIA CANNABINOID ASSAY (May 3, 2002)
  • K011275 — PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY (February 11, 2002)
  • K011185 — PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY (January 24, 2002)
  • K010868 — PSYCHEMEDICS RIA COCAINE ASSAY (November 6, 2001)

Other clearances for product code LAF

  • K203647 — SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay (December 22, 2021)
  • K210212 — Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair (December 15, 2021)
  • K201442 — Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus (July 31, 2020)
  • K170222 — Rapid Tox Cup II (August 15, 2017)
  • K153693 — Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Cal (March 18, 2016)
  • K142293 — Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methampheta (September 18, 2015)
  • K150096 — Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclid (March 4, 2015)
  • K150162 — First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (February 26, 2015)
  • K133047 — RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET (December 18, 2014)
  • K131652 — LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS (March 21, 2014)

FDA data resources