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Spectral Medical, Inc.
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
2
Inspections
1
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K183176
Endotoxin Activity Assay (EAA)
March 12, 2019
K170790
SAM CRRT Unit, SAM Cassette CRRT
December 13, 2017