Home / 510(k) Clearances / K874191

510(k) K874191

NDNA ANTIBODY TEST KIT by Lipogen, Inc. — Product Code LRM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1987
Date Received
October 14, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Dna Antibody (Enzyme-Labeled), Antigen, 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)
  • K880254 — SM ANTIBODY TEST KIT (April 6, 1988)

Other clearances for product code LRM

  • K101319 — IMMULISA DSDNA ANTIBODY ELISA (December 9, 2010)
  • K083381 — EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) (April 15, 2009)
  • K062183 — FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT (November 21, 2006)
  • K040811 — VARELISA SSDNA ANTIBODIES, MODEL 14896 (May 13, 2004)
  • K001900 — ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST (September 11, 2000)
  • K000477 — MDI DS-DNA TEST (March 1, 2000)
  • K994424 — DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM (February 18, 2000)
  • K993727 — BINDAZYME ANTI-DSDNA EIA KIT (December 21, 1999)
  • K984396 — LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213 (December 18, 1998)
  • K983422 — THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUN (November 18, 1998)