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Sienna Biotech, Inc.

FDA Regulatory Profile

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K970931COPALIS TORC TOTAL ANTIBODY ASSAYApril 24, 1997
K961784COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYSOctober 31, 1996
K955799COPALIS CMV TOTAL ANTIBODY ASSAYJuly 10, 1996