510(k) K800773

Device: DIGOCTK 125
Applicant: SORIN BIOMEDICA, FIAT, USA, INC.
510(k) number: K800773
Product code: LCS
Decision: Substantially Equivalent (SESE)
Decision date: 1980-04-24
Date received: 1980-04-07
Regulation: 862.3320
Classification name: Radioimmunoassay, Digoxin (125-i)
Medical specialty: Toxicology
Review panel: Toxicology
Device class: 2
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Address: 803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

2029372

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LCS #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K922353	DIGOXIN COATED TUBE RIA	Monobind	1992-08-24
K913562	QMS - DIGOXIN	Seradyn, Inc.	1991-08-30
K895828	INNOFLUOR DIGOXIN REAGENT SET	Innotron of Oregon, Inc.	1989-10-30
K884707	FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT	Cyberfluor, Inc.	1989-01-17
K874748	IMMPULSE DIGOXIN ASSAY REAGENTS	Sclavo, Inc.	1988-02-19
K864802	DART DIGOXIN ASSAY	Coulter Electronics, Inc.	1987-02-12
K820154	TDX DIGOXIN	Abbott Laboratories	1982-02-05
K812749	ULTRA-DIG	Antibodies, Inc.	1981-10-19
K803047	I-125 LABELED DIGOXIN	Pcl-Ria, Inc.	1980-12-22
K801490	DIGOXIN EIA KIT	M.A. Bioproducts	1980-07-14
K801413	AMERLEX DIGOXIN RIA KIT	Amersham Corp.	1980-07-08
K801202	DIGOXIN RADIOIMMUNOASSAY KIT	Technia Diagnostics , Ltd.	1980-06-20
K800997	DIGOXIN CLASP RIA KIT	E. R. Squibb & Sons, Inc.	1980-05-08
K770322	PHALDEBAS DIGOXIN RIA	Pharmacia, Inc.	1977-04-05

Legacy Summary#

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