ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400— 510(k) K043067

Name: FDA 510(k) clearance K043067
Creator: U.S. Food and Drug Administration
Published: 2005-05-31

Substantially Equivalent

Bioarray Solutions, Ltd.

FDA 510(k) clearance K043067 for ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400, Substantially Equivalent on 2005-05-31. Applicant: Bioarray Solutions, Ltd.. Device class: 2.

Clearance details

Applicant: Bioarray Solutions, Ltd.
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2004-11-08
Decision date: 2005-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warren, NJ, US

Download summary PDF View on FDA.gov ↗

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