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510(k) K790540

Device
RIA TEST KIT, CENTRIA DIGOXIN
Applicant
VENTREX LABORATORIES, INC.
510(k) number
K790540
Product code
DPB  
Decision
Substantially Equivalent (SESE)
Decision date
1979-04-23
Date received
1979-03-20
Regulation
862.3320
Classification name
Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Charcoal Sep.
Medical specialty
Toxicology
Review panel
Toxicology
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 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
K821811125I DIGOXIN RADIOIMMUNOASSAY KITCambridge Medical Technology1982-07-02
K820274DIGOXIN RADIOIMMUNOASSAYAmerican Diagnostic Corp.1982-02-23
K792153DIGOXIN RADIOIMMUNOASSAY SYSTEMRadioimmunoassay, Inc.1979-11-13
K790602RIA, DIGNXIN-125-IEndocrine-Metabolic Center1979-07-30
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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