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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.
510(k) Number K935229
Device Name OPUS DIGITOXIN
Applicant
Pb Diagnostic Systems, Inc.
151 University Ave.
Westwood,  MA  02090
Applicant Contact NANCY JOHANSEN
Correspondent
Pb Diagnostic Systems, Inc.
151 University Ave.
Westwood,  MA  02090
Correspondent Contact NANCY JOHANSEN
Regulation Number862.3300
Classification Product Code
DPG  
Date Received11/01/1993
Decision Date 12/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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