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Lipogen, Inc.

FDA 510(k) & PMA Approved Devices — 15 products

Total Devices15
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K902636 LIPOGEN RHEUMELISA DSDNA ASSAYLRY1990-06-28 View
510(k) K895997 RHEUMELISA ASSAY FOR RNP AUTOANTIBODIESLKO1989-11-06 View
510(k) K895996 RHEUMELISA ASSAY FOR SM AUTOANTIBODIESLKP1989-11-06 View
510(k) K895995 RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIESLJM1989-10-27 View
510(k) K895994 RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIESLJM1989-10-24 View
510(k) K894659 ANA ANTISERA CONTROL KITDHN1989-09-21 View
510(k) K892421 MODIFIED ACCESS R-CLONE ANA/RF SCREENING TESTLJM1989-05-09 View
510(k) K885048 ACCESS R-CLONE ANA PROFILE ASSAYDHC1989-01-24 View
510(k) K882740 ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAYLKJ1988-09-22 View
510(k) K880254 SM ANTIBODY TEST KITLKP1988-04-06 View
510(k) K874195 LA ANTIBODY TEST KITLJM1988-03-11 View
510(k) K874152 RNP ANTIBODY TEST KITLKO1988-03-11 View
510(k) K875246 LIPOGEN ANA TEST KITLJM1988-02-10 View
510(k) K874151 RF DIPSTICK TEST KITDHR1987-12-29 View
510(k) K874191 NDNA ANTIBODY TEST KITLRM1987-12-18 View
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