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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 K120138
Device Name BD MAX MRSA ASSAY, BD MAX INSTRUMENT
Applicant
BD DIAGNOSTICS (GENEOHM SCIENCES CANADA, INC)
7 LOVETON CIRCLE,
MAIL CODE 614
sparks,  MD  21152
Applicant Contact raymond j boule
Correspondent
BD DIAGNOSTICS (GENEOHM SCIENCES CANADA, INC)
7 LOVETON CIRCLE,
MAIL CODE 614
sparks,  MD  21152
Correspondent Contact raymond j boule
Regulation Number866.1640
Classification Product Code
NQX  
Subsequent Product Code
OOI  
Date Received01/17/2012
Decision Date 07/05/2012
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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