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510(k) K854017

ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT) by Lmd Laboratories — Product Code KHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1985
Date Received
September 30, 1985
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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