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510(k) K852231

ANA/LITE-HEP-2 TEST SYSTEM by Immuno-Products Industries — Product Code LJM

K852231 is an FDA 510(k) premarket notification submitted by Immuno-Products Industries for the device "ANA/LITE-HEP-2 TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on July 10, 1985. The device falls under product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls), a Class II device regulated under 21 CFR 866.5100. Immuno-Products Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1985
Date Received
May 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Device Class
Class II
Regulation Number
866.5100
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)
  • 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)
  • K810983 — ANTISMOOTH MUSCLE ANTIBODY TEST SYS (May 1, 1981)
  • K810982 — ANTITHYROID ANTIBODY IMMUNOFLUORESCENT (May 1, 1981)
  • K810984 — ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST (May 1, 1981)
  • K810985 — ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT (May 1, 1981)

Other clearances for product code LJM

  • K182353 — EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay (November 27, 2018)
  • K151559 — ImmuLisa Enhanced Centromere Antibody ELISA (March 11, 2016)
  • K140493 — ELIA SCL-70S IMMUNOASSAY (October 30, 2014)
  • K123880 — QUANTA FLASH CENTROMERE (February 7, 2014)
  • K131330 — GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT (January 28, 2014)
  • K131185 — ANA SCREEN ELISA (IGG) (July 15, 2013)
  • K083188 — VARELISA RECOMBI ANA SCREEN, MODEL 12 596 (March 13, 2009)
  • K050967 — VARELISA RECOMBI CTD SCREEN, MODEL 13096 (June 28, 2005)
  • K050625 — VARELISA RECOMBI ANA PROFILE, MODEL 18496 (April 26, 2005)
  • K041102 — IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA (October 26, 2004)

FDA data resources