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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, estriol
510(k) Number K802455
Device Name ESTRIOL-SQUIBB RIA KIT
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 Number862.1265
Classification Product Code
CGI  
Date Received10/08/1980
Decision Date 10/31/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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