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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name c. difficile toxin gene amplification assay
510(k) Number K133936
Device Name ARTUS C. DIFFICILE QS-RGQ MDX KIT
Applicant
QIAGEN, GMBH
1201 CLOPPER RD
gaithersburg,  MD  20878
Applicant Contact kimberly mapp
Correspondent
QIAGEN, GMBH
1201 CLOPPER RD
gaithersburg,  MD  20878
Correspondent Contact kimberly mapp
Regulation Number866.3130
Classification Product Code
OZN  
Subsequent Product Code
OOI  
Date Received12/23/2013
Decision Date 04/04/2014
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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