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FDA 510(k) Application Details - K132237
Device Classification Name
2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
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510(K) Number
K132237
Device Name
2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
Applicant
GEN-PROBE PRODESSE, INC.
20925 CROSSROADS CIRCLE
WAUKESHA, WI 53186 US
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Contact
EMILY ZIEGLER
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Regulation Number
866.3332
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Classification Product Code
OQW
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More FDA Info for this Product Code
Date Received
07/18/2013
Decision Date
08/26/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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