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FDA 510(k) Application Details - K981930
Device Classification Name
System, Test, Thyroid Autoantibody
More FDA Info for this Device
510(K) Number
K981930
Device Name
System, Test, Thyroid Autoantibody
Applicant
PHARMACIA & UPJOHN CO.
5094 ST. ANDREWS DR.
WESTERVILLLE, OH 43082 US
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Contact
KAREN E MATIS
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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
05/01/1998
Decision Date
07/07/1998
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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