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510(k) K043067

ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400 by Bioarray Solutions, Ltd. — Product Code LLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2005
Date Received
November 8, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extractable Antinuclear Antibody, Antigen And Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

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