BENZODIAZEPINE ENZYME IMMUNOASSAY— 510(k) K032365

Name: FDA 510(k) clearance K032365
Creator: U.S. Food and Drug Administration
Published: 2003-09-05

Substantially Equivalent

Lin-Zhi International, Inc.

FDA 510(k) clearance K032365 for BENZODIAZEPINE ENZYME IMMUNOASSAY, Substantially Equivalent on 2003-09-05. Applicant: Lin-Zhi International, Inc.. Device class: 2.

Clearance details

Applicant: Lin-Zhi International, Inc.
Product code: Code JXM
Device class: Class 2
Regulation: 21 CFR 862.3170
Advisory panel: Clinical Toxicology
Date received: 2003-07-31
Decision date: 2003-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Synnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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