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510(k) K810981

ANTI NDNA IMMUNOFLOURESCENT TEST SYS by Immuno-Products Industries — Product Code DHC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1981
Date Received
April 13, 1981
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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  • K843613 — FLUORESCENT TREPONEMEL ANTIBODY-ABSORB (October 31, 1984)
  • K831054 — ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB (April 27, 1983)
  • K830652 — ANTI N DNA-HCP (March 24, 1983)
  • K821576 — ANTINUCLEAR ANTIBODY SCREEN FLOURESC (June 10, 1982)
  • K810982 — ANTITHYROID ANTIBODY IMMUNOFLUORESCENT (May 1, 1981)
  • K810985 — ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT (May 1, 1981)
  • K810983 — ANTISMOOTH MUSCLE ANTIBODY TEST SYS (May 1, 1981)

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  • K930247 — HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE (March 10, 1993)
  • K930421 — ELIAS DSDNA ABS (March 10, 1993)
  • K914801 — IMMUNOWELL DSDNA ANTIBODY TEST (December 9, 1991)
  • K885048 — ACCESS R-CLONE ANA PROFILE ASSAY (January 24, 1989)
  • K872910 — IMMUNO/SLE (August 12, 1987)
  • K821385 — SERO/TEX LE TEST (May 28, 1982)
  • K810226 — SLE ANTI-N-DNA LATEX TEST (February 9, 1981)
  • K800991 — CORDIA N (May 8, 1980)