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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioassay, Triiodothyronine Uptake
510(k) Number K913663
Device Name AIA-PACK T-U
Applicant
Tosoh Corp.
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Applicant Contact PATRICIA B SHRADER
Correspondent
Tosoh Corp.
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Correspondent Contact PATRICIA B SHRADER
Regulation Number862.1715
Classification Product Code
KHQ  
Date Received08/16/1991
Decision Date 09/30/1991
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
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