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510(k) K844141

ENTAMOEBA HISTOLYTICA HK-9 ANTIGEN (AXENIC) by Lmd Laboratories — Product Code KHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1984
Date Received
October 23, 1984
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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