KHW · Class II · 21 CFR 866.3220

FDA Product Code KHW: Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

Leading manufacturers include Techlab, Inc., Diamedix Corp. and Cordis Corp..

18
Total
18
Cleared
87d
Avg days
1981
Since

FDA 510(k) Cleared Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. Devices (Product Code KHW)

18 devices
1–18 of 18
Cleared Jun 07, 2017
E. HISTOLYTICA QUIK CHEK
K170728
Techlab, Inc.
Microbiology · 90d
Cleared Dec 21, 1999
E. HISTOLYTICA II
K994101
Techlab, Inc.
Microbiology · 15d
Cleared Aug 30, 1996
E. HISTOLYTICA TEST
K955895
Techlab, Inc.
Microbiology · 248d
Cleared Aug 08, 1996
TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM
K954996
Trend Scientific, Inc.
Microbiology · 281d
Cleared Mar 09, 1995
ENTAMOEBA TEST
K944791
Techlab, Inc.
Microbiology · 162d
Cleared Oct 09, 1986
AMEBIASIS MICROASSAY
K863811
Diamedix Corp.
Microbiology · 9d
Cleared Aug 01, 1986
PDQ AMEBIASIS
K862473
Diamedix Corp.
Microbiology · 32d
Cleared Aug 28, 1985
HILLCREST AMEBIASIS IHA TEST
K853448
Hillcrest Biologicals
Microbiology · 12d
Cleared Feb 25, 1981
CORDIA A
K810046
Cordis Corp.
Immunology · 44d

About Product Code KHW - Regulatory Context