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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 Triiodothyronine
510(k) Number K897001
Device Name TOSOH AIA-PACK T3
Applicant
TOSOH CORP.
COLUMBIA SQUARE
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
TOSOH CORP.
COLUMBIA SQUARE
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number862.1710
Classification Product Code
CDP  
Date Received12/18/1989
Decision Date 03/09/1990
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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