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FDA 510(k) Application Details - K113319
Device Classification Name
Real Time Nucleic Acid Amplification System
More FDA Info for this Device
510(K) Number
K113319
Device Name
Real Time Nucleic Acid Amplification System
Applicant
QIAGEN, GMBH
1201 CLOPPER RD
GAITHERSBURG, MD 20878 US
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Contact
MELISSA MAHALL
Other 510(k) Applications for this Contact
Regulation Number
862.2570
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Classification Product Code
OOI
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More FDA Info for this Product Code
Date Received
11/10/2011
Decision Date
02/06/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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