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

Substantially Equivalent

Bioarray Solutions, Ltd.

Clearance details

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

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