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510(k) K981913

PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY by Chembio Diagnostic Systems, Inc. — Product Code LSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1999
Date Received
June 1, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Borrelia Serological Reagent
Device Class
Class II
Regulation Number
866.3830
Review Panel
MI
Submission Type

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