SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT
FDA 510(k) clearance K113433 · decided 2012-04-04
Clearance details
- K-number
- K113433
- Device name
- SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT
- Applicant
- Focus Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-11-21
- Decision date
- 2012-04-04
- Days to decision
- 135 days
- Clearance type
- Traditional
- Product code
- OMN
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cypress, 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 |
| XPERT C. DIFFICLE/EPI ASSAY (K110203) | Cepheid | 2011-04-07 |
| 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.