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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Free Thyroxine
510(k) Number K913493
Device Name AIA-PACK FT4
Applicant
TOSOH CORP.
COLUMBIA SQUARE
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Applicant Contact PATRICIA B SHRADER
Correspondent
TOSOH CORP.
COLUMBIA SQUARE
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Correspondent Contact PATRICIA B SHRADER
Regulation Number862.1695
Classification Product Code
CEC  
Date Received08/06/1991
Decision Date 09/10/1991
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
Recalls CDRH Recalls
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