510(k) DEN130032
- Device
- XPERT MTB/RIF ASSAY
- Applicant
- Cepheid
- 510(k) number
- DEN130032
- Product code
- PEU
- Decision
- Unknown (DENG)
- Decision date
- 2013-07-25
- Date received
- 2013-06-11
- 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
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- KERRY J FLOM
- Address
- 904 Caribbean Dr. Sunnyvale CA US 94089 94089
FDA Registration Numbers#
- 3016838963
- 3014214006
- 3004530258
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PEU#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K143302 | Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 | Cepheid | 2015-02-12 |