CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS)— 510(k) K033866

Name: FDA 510(k) clearance K033866
Creator: U.S. Food and Drug Administration
Published: 2004-04-07

Substantially Equivalent

Lin-Zhi International, Inc.

FDA 510(k) clearance K033866 for CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS), Substantially Equivalent on 2004-04-07. 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: 2003-12-12
Decision date: 2004-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Synnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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