illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10
FDA 510(k) clearance K160829 · decided 2016-06-13
Clearance details
- K-number
- K160829
- Device name
- illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10
- Applicant
- Meridian Bioscience, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-03-25
- Decision date
- 2016-06-13
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- OZX
- Device class
- 2
- Regulation number
- 866.3980
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cincinnati, OH, 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 |
|---|---|---|
| illumigene Mycoplasma DNA Amplification Assay (K152800) | Meridian Bioscience, Inc. | 2015-10-23 |
| ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT (K123423) | Meridian Bioscience, Inc. | 2013-06-05 |
Recalls involving this device
No recalls on record reference this clearance.