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FDA 510(k) Application Details - K123955
Device Classification Name
Real Time Nucleic Acid Amplification System
More FDA Info for this Device
510(K) Number
K123955
Device Name
Real Time Nucleic Acid Amplification System
Applicant
LIFE TECHNOLOGIES CORPORATION
5791 Van Allen Way
Carlsbad, CA 92008 US
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Contact
DEANNA VELLA
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
12/21/2012
Decision Date
03/08/2013
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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