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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, thyroid autoantibody
510(k) Number K052407
Device Name ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS
Applicant
FISHER DIAGNOSTICS
8365 VALLEY PIKE
MIDDLETOWN,  VA  22645 -0307
Applicant Contact M. HEATHER CAMERON
Correspondent
FISHER DIAGNOSTICS
8365 VALLEY PIKE
MIDDLETOWN,  VA  22645 -0307
Correspondent Contact M. HEATHER CAMERON
Regulation Number866.5870
Classification Product Code
JZO  
Subsequent Product Codes
JIT   JJX  
Date Received09/01/2005
Decision Date 07/18/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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