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Sienna Biotech, Inc.

FDA Regulatory Profile

Sienna Biotech, Inc. has 0 FDA recalls, 0 inspections, 3 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Apr 24, 1997

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances3Nov 8, 2026File dated Nov 2, 2026Current
Inspections0Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent 510(k) Clearances

K-NumberDeviceDate
K970931COPALIS TORC TOTAL ANTIBODY ASSAYApr 24, 1997
K961784COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYSOct 31, 1996
K955799COPALIS CMV TOTAL ANTIBODY ASSAYJul 10, 1996

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.