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FDA 510(k) Application Details - K093815
Device Classification Name
Antisera, Fluorescent, Human Metapneumovirus
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510(K) Number
K093815
Device Name
Antisera, Fluorescent, Human Metapneumovirus
Applicant
MILLIPORE CORPORATION
28820 SINGLE OAK DR.
TEMECULA, CA 92590 US
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Contact
CATHERINE KARAMAN
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Regulation Number
866.3980
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Classification Product Code
OMG
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Date Received
12/14/2009
Decision Date
03/12/2010
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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