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510(k) K100728

ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM by Zeus Scientific, Inc. — Product Code LSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2010
Date Received
March 15, 2010
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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