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510(k) K880254

SM ANTIBODY TEST KIT by Lipogen, Inc. — Product Code LKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1988
Date Received
January 20, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Sm Antibody, Antigen And Control
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)
  • K874152 — RNP ANTIBODY TEST KIT (March 11, 1988)

Other clearances for product code LKP

  • K202067 — EliA SmDP-S (July 14, 2021)
  • K183007 — EliA SmDP Immunoassay (December 24, 2018)
  • K132631 — EIA SMDP IMMUNOASSAY (August 29, 2014)
  • K123593 — QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP (April 17, 2013)
  • K051066 — THERATEST EL-ANA PROFILES (October 7, 2005)
  • K042629 — VARELISA SM ANTIBODIES, MODEL 18296 (December 8, 2004)
  • K024219 — LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115 (January 15, 2003)
  • K013263 — FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST (July 29, 2002)
  • K000755 — RHIGENE MESACUP2 TEST- SM (May 9, 2000)
  • K000312 — VARELISA SM ANTIBODIES (March 17, 2000)