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510(k) K900604

DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA by Biovir Laboratories, Inc. — Product Code KHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1990
Date Received
February 8, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Device Class
Class II
Regulation Number
866.3220
Review Panel
MI
Submission Type

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