COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT)— 510(k) K020763

Name: FDA 510(k) clearance K020763
Creator: U.S. Food and Drug Administration
Published: 2002-05-10

Substantially Equivalent

Lin-Zhi International, Inc.

FDA 510(k) clearance K020763 for COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT), Substantially Equivalent on 2002-05-10. Applicant: Lin-Zhi International, Inc.. Device class: 2.

Clearance details

Applicant: Lin-Zhi International, Inc.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 2002-03-07
Decision date: 2002-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DIO

view all

K213211 — Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System2022-01-27
K211973 — DRI Cocaine Metabolite Assay2021-09-24
K191638 — Pointe Scientific Cocaine Metabolite Enzyme Immunoassay2020-03-12
K181499 — DRI Cocaine Metabolite Assay2018-07-06
K170293 — Emit II Plus Cocaine Metabolite Assay2017-10-25

More clearances from Lin-Zhi International, Inc.

view all

K253082 — LZI Buprenorphine II Enzyme Immunoassay2026-01-16
K251634 — LZI Fentanyl III Enzyme Immunoassay2025-06-18
K202007 — LZI Oxycodone III Enzyme Immunoassay2020-09-17
K201938 — LZI Fentanyl II Enzyme Immunoassay2020-08-07
K201223 — LZI Tramadol Enzyme Immunoassay2020-06-04

Data sourced from openFDA. This site is unofficial and independent of the FDA.