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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 K854324
Device Name PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT
Applicant
Pantex, Div. Bio-Analysis, Inc.
1737 21st St.
Santa Monica,  CA  90404
Applicant Contact NEIL Y CHIAMORI
Correspondent
Pantex, Div. Bio-Analysis, Inc.
1737 21st St.
Santa Monica,  CA  90404
Correspondent Contact NEIL Y CHIAMORI
Regulation Number862.1700
Classification Product Code
CDX  
Date Received10/28/1985
Decision Date 12/05/1985
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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