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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 K991432
Device Name BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007
Applicant
BIOCHECK, INC.
9418 LASAINE AVE.
NORTHRIDGE,  CA  91325
Applicant Contact ROBIN J HELLEN
Correspondent
BIOCHECK, INC.
9418 LASAINE AVE.
NORTHRIDGE,  CA  91325
Correspondent Contact ROBIN J HELLEN
Regulation Number862.1700
Classification Product Code
KLI  
Date Received04/26/1999
Decision Date 06/02/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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