illumigene Pertussis DNA Amplification Assay— 510(k) K152285
Substantially EquivalentMeridian Bioscience, Inc.
FDA 510(k) clearance K152285 for illumigene Pertussis DNA Amplification Assay, Substantially Equivalent on 2015-11-10. Applicant: Meridian Bioscience, Inc.. Device class: 2.
Clearance details
- Applicant
- Meridian Bioscience, Inc.
- Product code
- Code OZZ
- Device class
- Class 2
- Regulation
- 21 CFR 866.3980
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cincinnati, OH, US
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