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FDA 510(k) Application Details - K991610
Device Classification Name
Thyroglobulin, Antigen, Antiserum, Control
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510(K) Number
K991610
Device Name
Thyroglobulin, Antigen, Antiserum, Control
Applicant
ZEUS SCIENTIFIC, INC.
200 EVANS WAY
BRANCHBURG, NJ 08876 US
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Contact
MARK J KOPNITSKY
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Regulation Number
866.5870
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Classification Product Code
DDC
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Date Received
05/10/1999
Decision Date
06/25/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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