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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 K093346
Device Name BD GENEOHM MRSA ACP ASSAY
Applicant
BD DIAGNOSTICS (GENEOHM SCIENCES, INC.)
6146 NANCY RIDGE DR.
san diego,  CA  92121
Applicant Contact raymond boule
Correspondent
BD DIAGNOSTICS (GENEOHM SCIENCES, INC.)
6146 NANCY RIDGE DR.
san diego,  CA  92121
Correspondent Contact raymond boule
Regulation Number866.1640
Classification Product Code
NQX  
Date Received10/26/2009
Decision Date 12/15/2009
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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