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Spectral Medical, Inc.

FDA Regulatory Profile

Spectral Medical, Inc. appears in FDA public data with 0 recalls, 2 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on March 12, 2019.

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K183176Endotoxin Activity Assay (EAA)March 12, 2019
K170790SAM CRRT Unit, SAM Cassette CRRTDecember 13, 2017

FDA data resources