ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10
FDA 510(k) clearance K110012 · decided 2011-02-24
Clearance details
- K-number
- K110012
- Device name
- ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10
- Applicant
- Meridian Bioscience, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-01-03
- Decision date
- 2011-02-24
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- OMN
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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| PORTRAIT ANALYZER (DEN120013) | Great Basin Scientific | 2012-04-30 |
| SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT (K113433) | Focus Diagnostics, Inc. | 2012-04-04 |
| XPERT C. DIFFICLE/EPI ASSAY (K110203) | Cepheid | 2011-04-07 |
| 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
| Record | Firm | Date |
|---|---|---|
| Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplificati recall (Z-0568-2026) | Meridian Bioscience Inc | 2025-11-19 |
| illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader recall (Z-1941-2014) | Meridian Bioscience Inc | 2014-06-27 |