510(k) K143302
- Device
- Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80
- Applicant
- CEPHEID
- 510(k) number
- K143302
- Product code
- PEU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-02-12
- Date received
- 2014-11-17
- Regulation
- 866.3373
- Classification name
- System, Nucleic Acid-based, Mycobacterium Tuberculosis Complex, 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
- KERRY J FLOM
- Address
- 904 Caribbean Dr. Sunnyvale CA US 94089 94089
FDA Registration Numbers#
- 3016838963
- 3014214006
- 3004530258
Source Documents#
Other 510(k) Records For Product Code PEU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN130032 | XPERT MTB/RIF ASSAY | Cepheid | 2013-07-25 |
Legacy Summary#
summary
FDA Review#
Decision Summary