Home / 510(k) Clearances / K190613

510(k) K190613

BD MAX Check-Points CPO by Check-Points Health B.V. — Product Code POC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2019
Date Received
March 11, 2019
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.

Other clearances for product code POC

  • K173263 — Xpert Carba-R (January 9, 2018)
  • K160901 — Xpert Carba-R (June 29, 2016)