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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 K820616
Device Name ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY
Applicant
E. R. SQUIBB & SONS, INC.
40 w 57th st.
new york,  NY  10019
Correspondent
E. R. SQUIBB & SONS, INC.
40 w 57th st.
new york,  NY  10019
Regulation Number862.1085
Classification Product Code
CIB  
Date Received03/08/1982
Decision Date 03/26/1982
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
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