KSA

Calibrator For Red-Cell And White-Cell Counting

Product code: KSA
Device name: Calibrator For Red-Cell And White-Cell Counting
Device class: Class 2
21 CFR: 21 CFR 864.8185
Medical specialty: Hematology
Marketing pathway: 510(K) Exempt
510(k) clearances (all years, FDA): 8 (all years; only the last 3 years are listed here)

Official FDA classification page: KSA

Classification and pathway per current FDA publications. Data from openFDA (CC0).