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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 K132822
Device Name BD MAX STAPHSR ASSAY, INSTRUMENT
Applicant
GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
2555 Boul. du Parc-Technologique
Quebec,  CA G1P 4S5
Applicant Contact PATRICIA DIONNE
Correspondent
GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
2555 Boul. du Parc-Technologique
Quebec,  CA G1P 4S5
Correspondent Contact PATRICIA DIONNE
Regulation Number866.1640
Classification Product Code
NQX  
Subsequent Product Code
OOI  
Date Received09/09/2013
Decision Date 11/26/2013
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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