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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 K842966
Device Name RENIN RADIOIMMUNOASSAY TEST KIT
Applicant
Serono Diagnostics, Inc.
11 Brooks Dr.
Bramtree,  MA  02184
Applicant Contact MIRIAM STELLA
Correspondent
Serono Diagnostics, Inc.
11 Brooks Dr.
Bramtree,  MA  02184
Correspondent Contact MIRIAM STELLA
Regulation Number862.1085
Classification Product Code
CIB  
Date Received07/27/1984
Decision Date 10/11/1984
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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