Immunotech Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
41
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K954188OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROLNovember 3, 1995
K946335OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIESOctober 20, 1995
K953498OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROLSeptember 8, 1995
K952789OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIESAugust 14, 1995
K952182OPTICLONE CD3/CD8 MONOCLONAL ANTIBODIESJuly 5, 1995
K950626OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIESMay 5, 1995
K934012FT4 RADIOIMMUNOASSAYNovember 16, 1993
K931228PROGESTERONE RADIOIMMUNOASSAY KITOctober 22, 1993
K911634MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TESTJune 24, 1991
K911153MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KTJune 18, 1991
K910411MICROZYME TSH ENZYME IMMUNOASSAY KITApril 3, 1991
K905777MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KITJanuary 30, 1991
K903993MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KITDecember 20, 1990
K904820MICROZYME T3 ENZYME IMMUNOASSAY KITDecember 18, 1990
K904635MICROZYME THC ENZYME IMMUNOASSAY TEST KITNovember 1, 1990
K903725EZ-BEAD TSH ENZYME IMMUNOASSAY KITOctober 26, 1990
K903609SEROTONIN ENZYME IMMUNOASSAYOctober 22, 1990
K903359MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KITAugust 22, 1990
K902922MICROZYME T4 ENZYME IMMUNOASSAY KITJuly 27, 1990
K902194MICRO DAU OPIATE ENZYME IMMUNOASSAY KITJuly 17, 1990