Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

CFH — Predicate Candidate Screening

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

40 daysmedian FDA review time

118 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K050790	SPOTCHEM II LDH TEST	Arkray, Inc.	2005-06-06	70
K020484	CARESIDE LDH	Careside, Inc.	2002-07-03	140
K895138	CLINISTAT LDH REAGENT TEST	Heraeus Kulzer, Inc.	1989-10-19	64
K894578	IQ LDH	Bd Becton Dickinson Vacutainer Systems Preanalytic	1989-10-17	85
K880630	LACTATE DEHYDROGENASE (LDH-L)	Tech-Co, Inc.	1988-03-16	29
K860349	LACTATE DEHYDROGENASE (LDH) REAGENT SET	Sterling Diagnostics, Inc.	1986-02-28	29
K852391	EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE	Helena Laboratories	1985-10-01	118
K842452	WAKO LDH CII TEST	Wako Chemicals USA, Inc.	1984-08-15	54
K820768	COLORIMETRIC LDH REAGENT SET	Biorent Diagnostic, Inc.	1982-04-14	23
K812836	LDH REAGENT SET	Anco Medical Reagents & Assoc.	1981-10-09	0
K782176	HYCEL LDH-INT TEST	Hycel, Inc.	1979-01-26	29
K771343	LDH-INT TEST	Hycel, Inc.	1977-08-10	21
K760009	COLORIMETRIC DETERMINATION (LDH)	The Dow Chemical Co.	1976-07-20	40

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