510(k) DEN120013
- Device
- PORTRAIT ANALYZER
- Applicant
- Great Basin Scientific
- 510(k) number
- DEN120013
- Product code
- OMN
- Decision
- Unknown (DENG)
- Decision date
- 2012-04-30
- Date received
- 2012-03-02
- Regulation
- 866.2660
- Classification name
- C. Difficile Nucleic Acid Amplification Test Assay
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- LARRY REA
- Address
- 2441 S. 3850 W. Salt Lake City UT US 84120 84120
FDA Registration Numbers#
- 2023365
- 3004530258
- 3016838963
- 2022994
- 1524213
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code OMN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K113433 | SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT | Focus Diagnostics, Inc. | 2012-04-04 |
| K110203 | XPERT C. DIFFICLE/EPI ASSAY | Cepheid | 2011-04-07 |
| K110012 | ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10 | Meridian Bioscience, Inc. | 2011-02-24 |
| K100818 | ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920 | Meridian Bioscience, Inc. | 2010-07-09 |