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510(k) K935229

Device
OPUS DIGITOXIN
Applicant
PB DIAGNOSTIC SYSTEMS, INC.
510(k) number
K935229
Product code
DPG  
Decision
Substantially Equivalent (SESE)
Decision date
1993-12-22
Date received
1993-11-01
Regulation
862.3300
Classification name
Radioimmunoassay, Digitoxin (125-i), Rabbit Antibody, Coated Tube Sep.
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
NANCY JOHANSEN
Address
151 University Ave. Westwood MA US 02090 02090

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DPG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K812129COAT-A-COUNT DIGITOXIN RIA KITDiagnostic Products Corp.1981-08-13
K780075RIALYZE DIGOXINMiles Laboratories, Inc.1978-02-28

Legacy Summary#

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FDA Review#

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