PORTRAIT ANALYZER
FDA 510(k) clearance DEN120013 · decided 2012-04-30
Clearance details
- K-number
- DEN120013
- Device name
- PORTRAIT ANALYZER
- Applicant
- Great Basin Scientific
- Decision
- Unknown
- Date received
- 2012-03-02
- Decision date
- 2012-04-30
- Days to decision
- 59 days
- Clearance type
- Post-NSE
- Product code
- OMN
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT (K113433) | Focus Diagnostics, Inc. | 2012-04-04 |
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| ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10 (K110012) | Meridian Bioscience, Inc. | 2011-02-24 |
| ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920 (K100818) | Meridian Bioscience, Inc. | 2010-07-09 |
Recalls involving this device
No recalls on record reference this clearance.