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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 K940004
Device Name AI-PHOTODIAGNOSTIC
Applicant
Pharmarceutical Discovery Corp.
7 Westchester Plz.
Elmsford,  NY  10523
Applicant Contact SOLOMON S STEINER, PH.D
Correspondent
Pharmarceutical Discovery Corp.
7 Westchester Plz.
Elmsford,  NY  10523
Correspondent Contact SOLOMON S STEINER, PH.D
Regulation Number862.1085
Classification Product Code
CIB  
Date Received01/03/1994
Decision Date 08/04/1995
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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