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510(k) K810981

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

K810981 is an FDA 510(k) premarket notification submitted by Immuno-Products Industries for the device "ANTI NDNA IMMUNOFLOURESCENT TEST SYS". The FDA issued a decision of Substantially Equivalent on April 29, 1981. The device falls under product code DHC (System, Test, Systemic Lupus Erythematosus), a Class II device regulated under 21 CFR 866.5820. Immuno-Products Industries has at least 10 other 510(k) clearances on record.

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

Other clearances by Immuno-Products Industries

  • K853122 — IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED (September 19, 1985)
  • K852230 — ANA/LITE-RL TEST SYSTEM (July 10, 1985)
  • K852231 — ANA/LITE-HEP-2 TEST SYSTEM (July 10, 1985)
  • 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)
  • K810985 — ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT (May 1, 1981)
  • K810984 — ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST (May 1, 1981)
  • K810983 — ANTISMOOTH MUSCLE ANTIBODY TEST SYS (May 1, 1981)

Other clearances for product code DHC

  • K001352 — REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT (April 9, 2001)
  • K001398 — REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT (March 30, 2001)
  • 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)

FDA data resources