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Sysmex Corporation of America

FDA Regulatory Profile

Sysmex Corporation of America appears in FDA public data with 0 recalls, 3 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on June 25, 2002.

Summary

Total Recalls
0
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K021241SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800IJune 25, 2002
K020496HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, April 12, 2002
K001683SYSMEX R-500August 21, 2000

FDA data resources