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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Digoxin (125-I)
510(k) Number K800997
Device Name DIGOXIN CLASP 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 Number862.3320
Classification Product Code
LCS  
Date Received04/25/1980
Decision Date 05/08/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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