510(k) K173263
- Device
- Xpert Carba-R
- Applicant
- Cepheid
- 510(k) number
- K173263
- Product code
- POC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-01-09
- Date received
- 2017-10-11
- Regulation
- 866.1640
- Classification name
- System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Yi-Ping Lin
- Address
- 904 Caribbean Dr. Sunnyvale CA US 94089 94089
FDA Registration Numbers#
- 3016838963
- 1119779
- 3007420875
- 3004530258
Source Documents#
Other 510(k) Records For Product Code POC #
Legacy Summary#
summary
FDA Review#
Decision Summary