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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 K062120
Device Name CISBIO RENIN RIA TEST
Applicant
Cis Bio International
150 Cherry Ln. Rd.
East Stroudsburg,  PA  18301
Applicant Contact Gary Lehnus
Correspondent
Cis Bio International
150 Cherry Ln. Rd.
East Stroudsburg,  PA  18301
Correspondent Contact Gary Lehnus
Regulation Number862.1085
Classification Product Code
CIB  
Date Received07/25/2006
Decision Date 03/30/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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