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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 K123998
Device Name QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY
Applicant
QUIDEL CORP.
10165 MCKELLAR CT.
SAN DIEGO,  CA  92121
Applicant Contact Ronald H Lollar
Correspondent
QUIDEL CORP.
10165 MCKELLAR CT.
SAN DIEGO,  CA  92121
Correspondent Contact Ronald H Lollar
Regulation Number866.3130
Classification Product Code
OZN  
Subsequent Product Code
OOI  
Date Received12/26/2012
Decision Date 03/08/2013
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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