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FDA 510(k) Application Details - K971835
Device Classification Name
Thyroglobulin, Antigen, Antiserum, Control
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510(K) Number
K971835
Device Name
Thyroglobulin, Antigen, Antiserum, Control
Applicant
MONOBIND
729 WEST 16TH ST., C-4
COSTA MESA, CA 92627 US
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Contact
FREDERICK R JEROME
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Regulation Number
866.5870
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Classification Product Code
DDC
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More FDA Info for this Product Code
Date Received
05/19/1997
Decision Date
07/03/1997
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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