Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

KHW — Predicate Candidate Screening

18 FDA 510(k) clearances under this product code; the 50 most recent screened below.

48 daysmedian FDA review time

248 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
K170728	E. HISTOLYTICA QUIK CHEK	Techlab, Inc.	2017-06-07	90
K994101	E. HISTOLYTICA II	Techlab, Inc.	1999-12-21	15
K955895	E. HISTOLYTICA TEST	Techlab, Inc.	1996-08-30	248
K954996	TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTE	Trend Scientific, Inc.	1996-08-08	281
K944791	ENTAMOEBA TEST	Techlab, Inc.	1995-03-09	162
K900604	DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA	Biovir Laboratories, Inc.	1990-07-26	168
K890774	GIARDEIA(TM)	Antibodies, Inc.	1989-04-04	48
K890003	GIARDIA STOOL ANTIGEN TEST KIT	Lmd Laboratories	1989-03-14	70
K874849	PROSPECT/GIARDIA	Alexon Biomedical, Inc.	1988-01-05	41
K870318	AMEBIASIS ELISA TEST KIT	Lmd Laboratories	1987-08-11	195
K863811	AMEBIASIS MICROASSAY	Diamedix Corp.	1986-10-09	9
K862473	PDQ AMEBIASIS	Diamedix Corp.	1986-08-01	32
K854230	MEBIASIS AGAR GEL DIFFUSION KIT	Lmd Laboratories	1985-11-12	22
K854017	ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT)	Lmd Laboratories	1985-10-22	22
K853448	HILLCREST AMEBIASIS IHA TEST	Hillcrest Biologicals	1985-08-28	12
K844141	ENTAMOEBA HISTOLYTICA HK-9 ANTIGEN (AXENIC)	Lmd Laboratories	1984-12-06	44
K831133	AMEBIASIS BIO-ENZABEAD SCREEN KIT	Bionetic Laboratory Products	1983-06-08	62
K810046	CORDIA A	Cordis Corp.	1981-02-25	44

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda