illumigene Pertussis DNA Amplification Assay
FDA 510(k) clearance K152285 · decided 2015-11-10
Clearance details
- K-number
- K152285
- Device name
- illumigene Pertussis DNA Amplification Assay
- Applicant
- Meridian Bioscience, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-08-12
- Decision date
- 2015-11-10
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- OZZ
- 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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Recalls involving this device
No recalls on record reference this clearance.