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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.
510(k) Number K831188
Device Name CONNECTOR TUBE
Applicant
Medrad, Inc.
566 Alpha Dr.
Pittsburgh,  PA  15238
Applicant Contact LARRY KOPYTA
Correspondent
Medrad, Inc.
566 Alpha Dr.
Pittsburgh,  PA  15238
Correspondent Contact LARRY KOPYTA
Regulation Number862.3320
Classification Product Code
DOY  
Date Received04/12/1983
Decision Date 05/09/1983
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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