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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.
N. Billerica,  MA  01862
Applicant Contact SCHUTTENBURG
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
331 Treble Cove Rd.
N. 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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