SYSMEX UF-50
FDA 510(k) clearance K012372 · decided 2001-09-28
Clearance details
- K-number
- K012372
- Device name
- SYSMEX UF-50
- Applicant
- Sysmex Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-07-26
- Decision date
- 2001-09-28
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- LKM
- Device class
- 2
- Regulation number
- 864.5200
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Long Grove, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sysmex Corp.
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.