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510(k) K802461

Device
ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT
Applicant
IMMUNOTECH CORP.
510(k) number
K802461
Product code
LCW  
Decision
Substantially Equivalent (SESE)
Decision date
1980-10-31
Date received
1980-10-08
Regulation
862.3300
Classification name
Radioimmunoassay, Digitoxin (125-i)
Medical specialty
Toxicology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

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)DeviceApplicantDecision date
K834080MATCHED COMPONENT SET FOR DIGITOXINCambridge Medical Technology1984-02-04
K780766(125 I) DIGITOXIN RIA KITDiagnostic Products Corp.1978-07-27

Legacy Summary#

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FDA Review#

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