Product code KSW— Hematology
DOUBLE ELUTRA-PACK UNIT
- Classification name
- System, Processing For Frozen Blood
- Device class
- Class 2
- Regulation
- 21 CFR 864.9145
- Advisory panel
- Hematology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code KSW
FDA has cleared device under product code KSW, all in 1976, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code KSW
Recent clearances under product code KSW
Data sourced from openFDA. This site is unofficial and independent of the FDA.