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510(k) K902636

LIPOGEN RHEUMELISA DSDNA ASSAY by Lipogen, Inc. — Product Code LRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1990
Date Received
June 14, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Punch, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Lipogen, Inc.

  • 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)
  • K874152 — RNP ANTIBODY TEST KIT (March 11, 1988)

Other clearances for product code LRY

  • K933516 — ACU-E PUNCH (March 24, 1994)
  • K904869 — ELLIPSE PUNCH (March 6, 1991)
  • K896303 — BIOPSY PUNCH (February 13, 1990)
  • K874356 — PIN PUNCH (November 23, 1987)
  • K874357 — TAPERED PUNCH (November 23, 1987)
  • K872388 — NAIL SET (July 23, 1987)