510(k) K100818
- Device
- ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920
- Applicant
- MERIDIAN BIOSCIENCE, INC.
- 510(k) number
- K100818
- Product code
- OMN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-07-09
- Date received
- 2010-03-23
- Regulation
- 866.2660
- Classification name
- C. Difficile Nucleic Acid Amplification Test Assay
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Michelle L Smith
- Address
- 3471 River Hills Dr. Cincinnati OH US 45244 45244
FDA Registration Numbers#
- 2023365
- 3004530258
- 3016838963
- 2022994
- 1524213
Source Documents#
Other 510(k) Records For Product Code OMN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN120013 | PORTRAIT ANALYZER | Great Basin Scientific | 2012-04-30 |
| 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 |
Legacy Summary#
summary
FDA Review#
Decision Summary