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510(k) K152614

Xpert Carba-R by Cepheid — Product Code PMY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2016
Date Received
September 14, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
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 isolated bacterial colonies using nucleic acid amplification technology.

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