Home / 510(k) Clearances / K192433

510(k) K192433

LZI Methadone II Enzyme Immunoassay by Lin-Zhi International, Inc. — Product Code DJR

K192433 is an FDA 510(k) premarket notification submitted by Lin-Zhi International, Inc. for the device "LZI Methadone II Enzyme Immunoassay". The FDA issued a decision of Substantially Equivalent on October 4, 2019. The device falls under product code DJR (Enzyme Immunoassay, Methadone), a Class II device regulated under 21 CFR 862.3620. Lin-Zhi International, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2019
Date Received
September 5, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Methadone
Device Class
Class II
Regulation Number
862.3620
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)
  • 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)
  • K141320 — LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Cali (May 28, 2015)

Other clearances for product code DJR

  • K182779 — ARK EDDP Assay (November 21, 2018)
  • K170416 — LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 3 (June 26, 2017)
  • K160793 — First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign D (August 17, 2016)
  • K152025 — AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) (October 5, 2015)
  • K151395 — Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calib (July 24, 2015)
  • K151441 — First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (June 29, 2015)
  • K131232 — WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) (May 31, 2013)
  • K092272 — RANDOX METHADONE ASSAY (November 18, 2010)
  • K092258 — RANDOX METABOLITE (EDDP) ASSAY (November 9, 2010)
  • K092048 — ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP (April 19, 2010)

FDA data resources