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FDA 510(k) Application Details - K102952
Device Classification Name
Respiratory Virus Panel Nucleic Acid Assay System
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510(K) Number
K102952
Device Name
Respiratory Virus Panel Nucleic Acid Assay System
Applicant
GEN-PROBE PRODESSE, INC
W229 N1870 WESTWOOD DR
WAUKESHA, WI 53186 US
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Contact
EMILY ZIELGER
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Regulation Number
866.3980
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Classification Product Code
OCC
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More FDA Info for this Product Code
Date Received
10/05/2010
Decision Date
12/03/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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