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510(k) K001022

BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 by Biocheck, Inc. — Product Code JZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2000
Date Received
March 30, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Beta-2-Microglobulin Immunological
Device Class
Class II
Regulation Number
866.5630
Review Panel
IM
Submission Type

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