XW-100 Automated Hematology Analyzer for CLIA Waived Use
FDA 510(k) clearance K172604 · decided 2017-11-06
Clearance details
- K-number
- K172604
- Device name
- XW-100 Automated Hematology Analyzer for CLIA Waived Use
- Applicant
- Sysmex America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-08-30
- Decision date
- 2017-11-06
- Days to decision
- 68 days
- Clearance type
- Dual Track
- Product code
- GKZ
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Lincolnshire, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sysmex America
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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.