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FDA 510(k) Application Details - K023592
Device Classification Name
Thyroglobulin, Antigen, Antiserum, Control
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510(K) Number
K023592
Device Name
Thyroglobulin, Antigen, Antiserum, Control
Applicant
QUEST INTL., INC.
1938 N.E. 148TH TERR.
NORTH MIAMI, FL 33181 US
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Contact
ROBERT A CORT
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Regulation Number
866.5870
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Classification Product Code
DDC
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Date Received
10/25/2002
Decision Date
01/06/2003
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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