510(k) K152614
- Device
- Xpert Carba-R
- Applicant
- CEPHEID
- 510(k) number
- K152614
- Product code
- PMY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-03-07
- Date received
- 2015-09-14
- Regulation
- 866.1640
- Classification name
- System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-susceptible Gram Negative Organism, Colony
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SCOTT A. CAMPBELL
- Address
- 904 Caribbean Dr. Sunnyvale CA US 94089 94089
FDA Registration Numbers#
- 1524213
- 3016838963
- 3004530258
- 3012918440
Source Documents#
Other 510(k) Records For Product Code PMY #
Legacy Summary#
summary
FDA Review#
Decision Summary