Lumipulse G CA15-3
FDA 510(k) clearance K192524 · decided 2020-09-04
Clearance details
- K-number
- K192524
- Device name
- Lumipulse G CA15-3
- Applicant
- Fujirebio Diagnostics,Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-09-13
- Decision date
- 2020-09-04
- Days to decision
- 357 days
- Clearance type
- Traditional
- Product code
- MOI
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Malvern, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Fujirebio Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.