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FDA 510(k), K110203, XPERT C. DIFFICLE/EPI ASSAY
FDA 510(k), K110203, XPERT C. DIFFICLE/EPI ASSAY
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510(K) Number: K110203
Device Name: XPERT C. DIFFICLE/EPI ASSAY
Manufacturer: CEPHEID
Device Classification Name: c. difficile nucleic acid amplification test assay
Regulation Number: 866.2660
Classification Product Code: OMN
Date Received: 01/24/2011
Decision Date: 04/07/2011
Regulation Medical Specialty: Microbiology
Device Name: XPERT C. DIFFICLE/EPI ASSAY
Manufacturer: CEPHEID
Device Classification Name: c. difficile nucleic acid amplification test assay
Regulation Number: 866.2660
Classification Product Code: OMN
Date Received: 01/24/2011
Decision Date: 04/07/2011
Regulation Medical Specialty: Microbiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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