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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen
510(k) Number K091409
Model 05205727
Device Name LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727
Original Applicant
ROCHE MOLECULAR SYSTEMS, INC.
4300 hacienda dr.
pleasanton,  CA  94588 2722
Original Contact larry pietrelli
Regulation Number866.1640
Classification Product Code
NQX  
Subsequent Product Code
OOI  
Date Received05/13/2009
Decision Date 07/06/2010
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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