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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 K142721
Device Name cobas MRSA/SA Test
Applicant
ROCHE MOLECULAR SYSTEMS, INC.
4300 HACIENDA DRIVE
pleasanton,  CA  94588 -2722
Applicant Contact wilk von gustedt
Correspondent
ROCHE MOLECULAR SYSTEMS, INC.
4300 HACIENDA DRIVE
pleasanton,  CA  94588 -2722
Correspondent Contact wilk von gustedt
Regulation Number866.1640
Classification Product Code
NQX  
Subsequent Product Code
OOI  
Date Received09/23/2014
Decision Date 12/17/2014
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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