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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
510(k) Number K981377
Device Name ACE T4 REAGENT T4 CALIBRATORS
Applicant
SCHIAPPARELLI BIOSYSTEMS, INC.
368 PASSAIC AVE.
FAIRFIELD,  NJ  07004
Applicant Contact STEVEN DALESSIO
Correspondent
SCHIAPPARELLI BIOSYSTEMS, INC.
368 PASSAIC AVE.
FAIRFIELD,  NJ  07004
Correspondent Contact STEVEN DALESSIO
Regulation Number862.1700
Classification Product Code
KLI  
Subsequent Product Code
JIS  
Date Received04/16/1998
Decision Date 06/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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