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510(k) K142422

cobas Cdiff Test by Roche Molecular Systems, Inc. — Product Code OZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2015
Date Received
August 28, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
C. Difficile Toxin Gene Amplification Assay
Device Class
Class II
Regulation Number
866.3130
Review Panel
MI
Submission Type

Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.

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