Atlas FDA

KHW

18 FDA 510(k) clearances · Product code

48 daysmedian time to decision
248 days90th percentile
18clearances measured

FDA profile

Official device name
Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3220
Medical specialty
Microbiology
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RecordFirmDate
E. HISTOLYTICA QUIK CHEK (K170728)Techlab, Inc.2017-06-07
E. HISTOLYTICA II (K994101)Techlab, Inc.1999-12-21
E. HISTOLYTICA TEST (K955895)Techlab, Inc.1996-08-30
TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM (K954996)Trend Scientific, Inc.1996-08-08
ENTAMOEBA TEST (K944791)Techlab, Inc.1995-03-09
DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA (K900604)Biovir Laboratories, Inc.1990-07-26
GIARDEIA(TM) (K890774)Antibodies, Inc.1989-04-04
GIARDIA STOOL ANTIGEN TEST KIT (K890003)Lmd Laboratories1989-03-14
PROSPECT/GIARDIA (K874849)Alexon Biomedical, Inc.1988-01-05
AMEBIASIS ELISA TEST KIT (K870318)Lmd Laboratories1987-08-11
AMEBIASIS MICROASSAY (K863811)Diamedix Corp.1986-10-09
PDQ AMEBIASIS (K862473)Diamedix Corp.1986-08-01
MEBIASIS AGAR GEL DIFFUSION KIT (K854230)Lmd Laboratories1985-11-12
ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT) (K854017)Lmd Laboratories1985-10-22
HILLCREST AMEBIASIS IHA TEST (K853448)Hillcrest Biologicals1985-08-28
ENTAMOEBA HISTOLYTICA HK-9 ANTIGEN (AXENIC) (K844141)Lmd Laboratories1984-12-06
AMEBIASIS BIO-ENZABEAD SCREEN KIT (K831133)Bionetic Laboratory Products1983-06-08
CORDIA A (K810046)Cordis Corp.1981-02-25

Track KHW automatically

Every clearance here is in the API, with alerts when new ones post.