ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)— 510(k) K033094

Name: FDA 510(k) clearance K033094
Creator: U.S. Food and Drug Administration
Published: 2003-12-19

Substantially Equivalent

Lin-Zhi International, Inc.

FDA 510(k) clearance K033094 for ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT), Substantially Equivalent on 2003-12-19. 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: 2003-09-29
Decision date: 2003-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Synnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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