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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
Recalls CDRH Recalls
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