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510(k) K771877

Device
DIGOXIN RIA KIT
Applicant
ANTIBODIES INC.
510(k) number
K771877
Product code
DNJ  
Decision
Substantially Equivalent (SESE)
Decision date
1977-10-21
Date received
1977-10-04
Regulation
862.3320
Classification name
Radioimmunoassay, Digoxin (125-i), Goat Antibody, 2nd Antibody Sep.
Medical specialty
Toxicology
Review panel
Immunology
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 DNJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K771533DIGOXIN RIA KITG.D. Searle and Co.1977-08-25

Legacy Summary#

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FDA Review#

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