PREMIER Platinum HpSA PLUS
FDA 510(k) clearance K182559 · decided 2018-11-05
Clearance details
- K-number
- K182559
- Device name
- PREMIER Platinum HpSA PLUS
- Applicant
- Meridian Bioscience, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-09-17
- Decision date
- 2018-11-05
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- LYR
- Device class
- 1
- Regulation number
- 866.3110
- 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.