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FDA 510(k) Application Details - K990618
Device Classification Name
Immunohistochemistry Assay,Antibody,Progesterone Receptor
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510(K) Number
K990618
Device Name
Immunohistochemistry Assay,Antibody,Progesterone Receptor
Applicant
VENTANA MEDICAL SYSTEMS, INC.
3865 N. BUSINESS CENTER DR.
TUCSON, AZ 85705 US
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Contact
JUDITH FREDERICK
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Regulation Number
864.1860
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Classification Product Code
MXZ
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Date Received
02/25/1999
Decision Date
07/23/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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