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FDA 510(k) Application Details - K052407
Device Classification Name
System, Test, Thyroid Autoantibody
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510(K) Number
K052407
Device Name
System, Test, Thyroid Autoantibody
Applicant
FISHER DIAGNOSTICS
8365 VALLEY PIKE
MIDDLETOWN, VA 22645-0307 US
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Contact
M. HEATHER CAMERON
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Regulation Number
866.5870
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Classification Product Code
JZO
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More FDA Info for this Product Code
Date Received
09/01/2005
Decision Date
07/18/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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