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FDA 510(k) Application Details - K102314
Device Classification Name
Real Time Nucleic Acid Amplification System
More FDA Info for this Device
510(K) Number
K102314
Device Name
Real Time Nucleic Acid Amplification System
Applicant
FOCUS DIAGNOSTICS, INC.
11331 VALLEY VIEW ST
CYPRESS, CA 90630 US
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Contact
TARA VIVIANI
Other 510(k) Applications for this Contact
Regulation Number
862.2570
More FDA Info for this Regulation Number
Classification Product Code
OOI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/16/2010
Decision Date
10/29/2010
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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