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Lipogen, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K902636LIPOGEN RHEUMELISA DSDNA ASSAYJune 28, 1990
K895996RHEUMELISA ASSAY FOR SM AUTOANTIBODIESNovember 6, 1989
K895997RHEUMELISA ASSAY FOR RNP AUTOANTIBODIESNovember 6, 1989
K895995RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIESOctober 27, 1989
K895994RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIESOctober 24, 1989
K894659ANA ANTISERA CONTROL KITSeptember 21, 1989
K892421MODIFIED ACCESS R-CLONE ANA/RF SCREENING TESTMay 9, 1989
K885048ACCESS R-CLONE ANA PROFILE ASSAYJanuary 24, 1989
K882740ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAYSeptember 22, 1988
K880254SM ANTIBODY TEST KITApril 6, 1988
K874152RNP ANTIBODY TEST KITMarch 11, 1988
K874195LA ANTIBODY TEST KITMarch 11, 1988
K875246LIPOGEN ANA TEST KITFebruary 10, 1988
K874151RF DIPSTICK TEST KITDecember 29, 1987
K874191NDNA ANTIBODY TEST KITDecember 18, 1987