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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Total Triiodothyronine
510(k) Number K853703
Device Name VENTREZYME T3 IMMUNOASSAY T3
Applicant
VXR, INC.
217 READ ST.
PORTLAND,  ME  04103
Applicant Contact JAMES W CHAMPLIN
Correspondent
VXR, INC.
217 READ ST.
PORTLAND,  ME  04103
Correspondent Contact JAMES W CHAMPLIN
Regulation Number862.1710
Classification Product Code
CDP  
Date Received09/04/1985
Decision Date 10/04/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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