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510(k) K780316

Device
RABBIT ANTIBODY TO DIGOXIN
Applicant
PCL-RIA, INC.
510(k) number
K780316
Product code
DKA  
Decision
Substantially Equivalent (SESE)
Decision date
1978-03-17
Date received
1978-02-24
Regulation
862.3320
Classification name
Antiserum, Digoxin
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

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)DeviceApplicantDecision date
K934003STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAYBaxter Diagnostics, Inc.1994-11-22
K780498CBR-DIGOXIN ANTISERUMClinical Bioresearch1978-04-05

Legacy Summary#

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FDA Review#

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