Lumipulse G TP-N Immunoreaction Cartridge Set
FDA 510(k) clearance K153145 · decided 2016-07-05
Clearance details
- K-number
- K153145
- Device name
- Lumipulse G TP-N Immunoreaction Cartridge Set
- Applicant
- Fujirebio Diagnostics,Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-10-30
- Decision date
- 2016-07-05
- Days to decision
- 249 days
- Clearance type
- Traditional
- Product code
- LIP
- Device class
- 2
- Regulation number
- 866.3830
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Malvern, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.