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510(k) K173263

Xpert Carba-R by Cepheid — Product Code POC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2018
Date Received
October 11, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

To detect the presence of genetic markers of antimicrobial resistance by testing directly from clinical specimens using nucleic acid amplification technology.

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Other clearances for product code POC

  • K190613 — BD MAX Check-Points CPO (August 29, 2019)
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