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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 K071026
Device Name BD GENEOHM STAPHSR ASSAY
Applicant
BD DIAGNOSTICS (GENEOHM SCIENCES CANADA, INC)
6146 NANCY RIDGE DRIVE
SAN DIEGO,  CA  92121
Applicant Contact RAYMOND BOULE
Correspondent
BD DIAGNOSTICS (GENEOHM SCIENCES CANADA, INC)
6146 NANCY RIDGE DRIVE
SAN DIEGO,  CA  92121
Correspondent Contact RAYMOND BOULE
Regulation Number866.1640
Classification Product Code
NQX  
Date Received04/11/2007
Decision Date 12/20/2007
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
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