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FDA 510(k) Application Details - K983031
Device Classification Name
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
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510(K) Number
K983031
Device Name
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Applicant
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER, NY 14626-5101 US
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Contact
ANNE ZAVERTNIK
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Regulation Number
866.6010
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Classification Product Code
LOJ
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More FDA Info for this Product Code
Date Received
08/31/1998
Decision Date
12/18/1998
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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