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510(k) K834080

Device
MATCHED COMPONENT SET FOR DIGITOXIN
Applicant
CAMBRIDGE MEDICAL TECHNOLOGY
510(k) number
K834080
Product code
LCW  
Decision
Substantially Equivalent (SESE)
Decision date
1984-02-04
Date received
1983-11-28
Regulation
862.3300
Classification name
Radioimmunoassay, Digitoxin (125-i)
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 LCW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K802461ENDAB DIGITOXIN ENZYME IMMUNOASSAY KITImmunotech Corp.1980-10-31
K780766(125 I) DIGITOXIN RIA KITDiagnostic Products Corp.1978-07-27

Legacy Summary#

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FDA Review#

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