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FDA 510(k) Application Details - K082688
Device Classification Name
Human Metapneumovirus (Hmpv) Rna Assay System
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510(K) Number
K082688
Device Name
Human Metapneumovirus (Hmpv) Rna Assay System
Applicant
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
OEM
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More FDA Info for this Product Code
Date Received
09/15/2008
Decision Date
11/07/2008
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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