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

LCS — Predicate Candidate Screening

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

22 daysmedian FDA review time

93 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K922353	DIGOXIN COATED TUBE RIA	Monobind	1992-08-24	97
K913562	QMS - DIGOXIN	Seradyn, Inc.	1991-08-30	21
K895828	INNOFLUOR DIGOXIN REAGENT SET	Innotron of Oregon, Inc.	1989-10-30	28
K884707	FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT	Cyberfluor, Inc.	1989-01-17	69
K874748	IMMPULSE DIGOXIN ASSAY REAGENTS	Sclavo, Inc.	1988-02-19	93
K864802	DART DIGOXIN ASSAY	Coulter Electronics, Inc.	1987-02-12	65
K820154	TDX DIGOXIN	Abbott Laboratories	1982-02-05	17
K812749	ULTRA-DIG	Antibodies, Inc.	1981-10-19	20
K803047	I-125 LABELED DIGOXIN	Pcl-Ria, Inc.	1980-12-22	21
K801490	DIGOXIN EIA KIT	M.A. Bioproducts	1980-07-14	18
K801413	AMERLEX DIGOXIN RIA KIT	Amersham Corp.	1980-07-08	22
K801202	DIGOXIN RADIOIMMUNOASSAY KIT	Technia Diagnostics , Ltd.	1980-06-20	32
K800997	DIGOXIN CLASP RIA KIT	E. R. Squibb & Sons, Inc.	1980-05-08	13
K800773	DIGOCTK 125	Sorin Biomedica, Fiat, USA, Inc.	1980-04-24	17
K770322	PHALDEBAS DIGOXIN RIA	Pharmacia, Inc.	1977-04-05	47

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