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510(k) K842484

LEAP LE TEST KIT by Cooper Biomedical, Inc. — Product Code LKJ

K842484 is an FDA 510(k) premarket notification submitted by Cooper Biomedical, Inc. for the device "LEAP LE TEST KIT". The FDA issued a decision of Substantially Equivalent on July 11, 1984. The device falls under product code LKJ (Antinuclear Antibody, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Cooper Biomedical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1984
Date Received
June 25, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody, Antigen, Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Cooper Biomedical, Inc.

  • K864512 — IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO (February 13, 1987)
  • K863868 — IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT (February 13, 1987)
  • K863301 — DEMAND TOTAL PROTEIN (September 26, 1986)
  • K861926 — WORTHINGTON HDL PRECIPITATING REAGENT SET (June 27, 1986)
  • K854130 — DEMAND ETHYL ALCOHOL (November 5, 1985)
  • K853949 — DEMAND ACID PHOSPHATASE REAGENT (October 16, 1985)
  • K852262 — ASSIST CLINICAL CHEMISTRY ANALYZER (June 25, 1985)
  • K851285 — RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMI (June 17, 1985)
  • K851284 — RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM (June 11, 1985)
  • K851286 — RADIAL IMMUNODIFFUSION PLATES C3 & C4 (June 5, 1985)

Other clearances for product code LKJ

  • K210902 — EliA Ro52, EliA Ro60 (July 27, 2022)
  • K113610 — ANA-SCREEN WITH MDSS (July 9, 2012)
  • K082759 — ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMU (April 10, 2009)
  • K081104 — AESKULISA ANA HEP-2, REF 30-7115US (May 2, 2008)
  • K041658 — BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL (December 20, 2004)
  • K042416 — ATHENA MULTI-LYTE ANA-II TEST SYSTEM (October 8, 2004)
  • K034013 — REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 (January 8, 2004)
  • K030775 — AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM (May 12, 2003)
  • K024232 — LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113 (January 17, 2003)
  • K024218 — LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 (January 17, 2003)

FDA data resources