FDA 510(k) Applications for Medical Device Product Code "KHW"
(Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.)

FDA 510(k) Number Applicant Device Name Decision Date
K994101 TECHLAB, INC. E. HISTOLYTICA II 12/21/1999
K170728 TECHLAB, Inc. E. HISTOLYTICA QUIK CHEK 06/07/2017
K955895 TECHLAB, INC. E. HISTOLYTICA TEST 08/30/1996
K954996 TREND SCIENTIFIC, INC. TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM 08/08/1996


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