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FDA 510(k) Application Details - K140887
Device Classification Name
Dna-Reagents, Neisseria
More FDA Info for this Device
510(K) Number
K140887
Device Name
Dna-Reagents, Neisseria
Applicant
ROCHE MOLECULAR SYSTEMS, INC.
4300 HACIENDA DRIVE
PLEASANTON, CA 94588-2722 US
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Contact
WILK VON GUSTEDT
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Regulation Number
866.3390
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Classification Product Code
LSL
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More FDA Info for this Product Code
Date Received
04/07/2014
Decision Date
05/05/2014
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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