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510(k) K944791

ENTAMOEBA TEST by Techlab, Inc. — Product Code KHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1995
Date Received
September 28, 1994
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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  • K890774 — GIARDEIA(TM) (April 4, 1989)
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  • K874849 — PROSPECT/GIARDIA (January 5, 1988)
  • K870318 — AMEBIASIS ELISA TEST KIT (August 11, 1987)
  • K863811 — AMEBIASIS MICROASSAY (October 9, 1986)