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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
Device Name LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727
Applicant
ROCHE MOLECULAR SYSTEMS, INC.
4300 HACIENDA DR.
PLEASANTON,  CA  94588 -2722
Applicant Contact LARRY PIETRELLI
Correspondent
ROCHE MOLECULAR SYSTEMS, INC.
4300 HACIENDA DR.
PLEASANTON,  CA  94588 -2722
Correspondent 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 (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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