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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name bordetella pertussis dna assay system
510(k) Number K143206
Device Name AmpliVue Bordetella Assay
Applicant
QUIDEL CORPORATION
2005 EAST STATE STREET
SUITE 100
athens,  OH  45701
Applicant Contact ronald h. lollar
Correspondent
QUIDEL CORPORATION
2005 EAST STATE STREET
SUITE 100
athens,  OH  45701
Correspondent Contact ronald h. lollar
Regulation Number866.3980
Classification Product Code
OZZ  
Date Received11/07/2014
Decision Date 12/10/2014
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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