XPERT C. DIFFICLE/EPI ASSAY
FDA 510(k) clearance K110203 · decided 2011-04-07
Clearance details
- K-number
- K110203
- Device name
- XPERT C. DIFFICLE/EPI ASSAY
- Applicant
- Cepheid
- Decision
- Substantially Equivalent
- Date received
- 2011-01-24
- Decision date
- 2011-04-07
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- OMN
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PORTRAIT ANALYZER (DEN120013) | Great Basin Scientific | 2012-04-30 |
| SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT (K113433) | Focus Diagnostics, Inc. | 2012-04-04 |
| 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.