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510(k) K113661

LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS by Lin-Zhi International, Inc. — Product Code LAF

K113661 is an FDA 510(k) premarket notification submitted by Lin-Zhi International, Inc. for the device "LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS". The FDA issued a decision of Substantially Equivalent on January 23, 2012. The device falls under product code LAF (Gas Chromatography, Methamphetamine), a Class II device regulated under 21 CFR 862.3610. Lin-Zhi International, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2012
Date Received
December 13, 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 Lin-Zhi International, Inc.

  • K253082 — LZI Buprenorphine II Enzyme Immunoassay (January 16, 2026)
  • K251634 — LZI Fentanyl III Enzyme Immunoassay (June 18, 2025)
  • K202007 — LZI Oxycodone III Enzyme Immunoassay (September 17, 2020)
  • K201938 — LZI Fentanyl II Enzyme Immunoassay (August 7, 2020)
  • K201223 — LZI Tramadol Enzyme Immunoassay (June 4, 2020)
  • K192299 — LZI Cotinine II Enzyme Immunoassay (November 21, 2019)
  • K192433 — LZI Methadone II Enzyme Immunoassay (October 4, 2019)
  • K181159 — LZI Fentanyl Enzyme Immunoassay (December 3, 2018)
  • DEN170010 — LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay (April 20, 2018)
  • K170416 — LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 3 (June 26, 2017)

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