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FDA 510(k) Application Details - K110968
Device Classification Name
Respiratory Virus Panel Nucleic Acid Assay System
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510(K) Number
K110968
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
KAREN HARRINGTON
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Regulation Number
866.3980
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Classification Product Code
OCC
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Date Received
04/06/2011
Decision Date
06/27/2011
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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