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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dna-reagents, legionella
510(k) Number K033861
Device Name BD PROBETEC ET LEGIONELLA PNEUMOPHILA (LP) AMPLIFIED DNA ASSAY
Applicant
BECTON, DICKINSON & CO.
7 LOVETON CIR.
SPARKS,  MD  21152 -0999
Applicant Contact COLLEEN A KISTLER
Correspondent
BECTON, DICKINSON & CO.
7 LOVETON CIR.
SPARKS,  MD  21152 -0999
Correspondent Contact COLLEEN A KISTLER
Regulation Number866.3300
Classification Product Code
LQH  
Date Received12/12/2003
Decision Date 03/09/2004
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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