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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 K954299
Device Name BUHLMANN ANGIOSTENSIN II RIA
Applicant
Buhlmann Laboratories AG
P.O. Box 451
Windham,  NH  03087
Applicant Contact RICHARD E CONLEY
Correspondent
Buhlmann Laboratories AG
P.O. Box 451
Windham,  NH  03087
Correspondent Contact RICHARD E CONLEY
Regulation Number862.1085
Classification Product Code
CIB  
Date Received09/14/1995
Decision Date 10/19/1995
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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