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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Total Thyroxine
510(k) Number K790477
Device Name TY RIA KIT, AUTOMATED ASSAY SYSTEM
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 Number862.1700
Classification Product Code
CDX  
Date Received03/09/1979
Decision Date 04/26/1979
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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