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Cytotech, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K882829CIRCULATING IMMUNE COMPLEXES CONTROLSAugust 4, 1988
K874379CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAYNovember 25, 1987
K873249ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLSSeptember 22, 1987
K872426CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAYJuly 23, 1987
K871801CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KITJune 9, 1987
K864315CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAYFebruary 2, 1987
K862838CYTOTECH HSV IGG ENZYME IMMUNOASSAYDecember 9, 1986
K863363CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAYNovember 13, 1986
K862649CYTOTECH CIC ENZYME IMMUNOASSAYSeptember 4, 1986
K860493CYTOTECH CMV IGG EIAMay 20, 1986