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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 K802456
Device Name T4-SQUIBB RIA KIT
Applicant
E. R. Squibb & Sons, Inc.
Georges Rd.
New Brunswick,  NJ 
Correspondent
E. R. Squibb & Sons, Inc.
Georges Rd.
New Brunswick,  NJ 
Regulation Number862.1700
Classification Product Code
CDX  
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
Predetermined Change
Control Plan Authorized		 No
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