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510(k) K821811

Device
125I DIGOXIN RADIOIMMUNOASSAY KIT
Applicant
CAMBRIDGE MEDICAL TECHNOLOGY
510(k) number
K821811
Product code
DPB  
Decision
Substantially Equivalent (SESE)
Decision date
1982-07-02
Date received
1982-06-18
Regulation
862.3320
Classification name
Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Charcoal Sep.
Medical specialty
Toxicology
Review panel
Clinical Chemistry
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 DPB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K853021OPTIMATE DIGOXIN TESTMiles Laboratories, Inc.1985-08-07
K823014DIGOXIN KITPcl-Ria, Inc.1982-11-01
K820274DIGOXIN RADIOIMMUNOASSAYAmerican Diagnostic Corp.1982-02-23
K792153DIGOXIN RADIOIMMUNOASSAY SYSTEMRadioimmunoassay, Inc.1979-11-13
K790602RIA, DIGNXIN-125-IEndocrine-Metabolic Center1979-07-30
K790540RIA TEST KIT, CENTRIA DIGOXINVentrex Laboratories, Inc.1979-04-23
K772306125I DIGOXIN TEST SETWien Laboratories, Inc.1977-12-22
K771525125 I DIGOXIN RIA KITDiagnostic Products Corp.1977-10-14
K760883DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAYNuclear Medical Laboratories, Inc.1976-11-19

Legacy Summary#

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FDA Review#

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