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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 K132726
Device Name ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM
Applicant
PRIMERADX
171 FORBES BLVD
SUITE 1000
mansfield,  MA  02048
Applicant Contact fayyaz memnon
Correspondent
PRIMERADX
171 FORBES BLVD
SUITE 1000
mansfield,  MA  02048
Correspondent Contact fayyaz memnon
Regulation Number866.3130
Classification Product Code
OZN  
Subsequent Product Code
NSU  
Date Received08/30/2013
Decision Date 11/29/2013
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
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