510(k) K780498

Device: Cbr-digoxin Antiserum
Applicant: CLINICAL BIORESEARCH
510(k) number: K780498
Product code: DKA
Decision: Substantially Equivalent (SESE)
Decision date: 1978-04-05
Date received: 1978-03-28
Regulation: 862.3320
Classification name: Antiserum, Digoxin
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 DKA#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K934003	STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY	Baxter Diagnostics, Inc.	1994-11-22
K780316	RABBIT ANTIBODY TO DIGOXIN	Pcl-Ria, Inc.	1978-03-17