AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT)— 510(k) K020395

Name: FDA 510(k) clearance K020395
Creator: U.S. Food and Drug Administration
Published: 2002-06-04

Substantially Equivalent

Lin-Zhi International, Inc.

FDA 510(k) clearance K020395 for AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT), Substantially Equivalent on 2002-06-04. Applicant: Lin-Zhi International, Inc.. Device class: 2.

Clearance details

Applicant: Lin-Zhi International, Inc.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2002-02-06
Decision date: 2002-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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