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510(k) K885048

ACCESS R-CLONE ANA PROFILE ASSAY by Lipogen, Inc. — Product Code DHC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1989
Date Received
December 7, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Systemic Lupus Erythematosus
Device Class
Class II
Regulation Number
866.5820
Review Panel
IM
Submission Type

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  • 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)
  • 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)

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