510(k) K780766

Device: (125 I) Digitoxin Ria Kit
Applicant: DIAGNOSTIC PRODUCTS CORP.
510(k) number: K780766
Product code: LCW
Decision: Substantially Equivalent (SESE)
Decision date: 1978-07-27
Date received: 1978-05-05
Regulation: 862.3300
Classification name: Radioimmunoassay, Digitoxin (125-I)
Medical specialty: Clinical Toxicology
Review panel: Clinical 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

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LCW#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K834080	MATCHED COMPONENT SET FOR DIGITOXIN	Cambridge Medical Technology	1984-02-04
K802461	ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT	Immunotech Corp.	1980-10-31