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510(k) K875246

LIPOGEN ANA TEST KIT by Lipogen, Inc. — Product Code LJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1988
Date Received
December 22, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Lipogen, Inc.

  • K902636 — LIPOGEN RHEUMELISA DSDNA ASSAY (June 28, 1990)
  • K895996 — RHEUMELISA ASSAY FOR SM AUTOANTIBODIES (November 6, 1989)
  • K895997 — RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES (November 6, 1989)
  • K895995 — RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES (October 27, 1989)
  • K895994 — RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES (October 24, 1989)
  • K894659 — ANA ANTISERA CONTROL KIT (September 21, 1989)
  • K892421 — MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST (May 9, 1989)
  • K885048 — ACCESS R-CLONE ANA PROFILE ASSAY (January 24, 1989)
  • K882740 — ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY (September 22, 1988)
  • K880254 — SM ANTIBODY TEST KIT (April 6, 1988)

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  • K050967 — VARELISA RECOMBI CTD SCREEN, MODEL 13096 (June 28, 2005)
  • K050625 — VARELISA RECOMBI ANA PROFILE, MODEL 18496 (April 26, 2005)
  • K041102 — IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA (October 26, 2004)