510(k) K160901
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 29, 2016
- Date Received
- April 1, 2016
- 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.