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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, angiotensin i and renin
510(k) Number K850054
Device Name RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI
Applicant
E.I. DUPONT DE NEMOURS & CO., INC.
331 TREBLE COVE RD.
NORTH BILLERICA,  MA  01862
Applicant Contact SCHUTTENBURG
Correspondent
E.I. DUPONT DE NEMOURS & CO., INC.
331 TREBLE COVE RD.
NORTH BILLERICA,  MA  01862
Correspondent Contact SCHUTTENBURG
Regulation Number862.1085
Classification Product Code
CIB  
Date Received01/08/1985
Decision Date 03/29/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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