illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10— 510(k) K160829
Substantially EquivalentMeridian Bioscience, Inc.
FDA 510(k) clearance K160829 for illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10, Substantially Equivalent on 2016-06-13. Applicant: Meridian Bioscience, Inc..
Clearance details
- Applicant
- Meridian Bioscience, Inc.
- Product code
- Code OZX
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cincinnati, OH, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.