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510(k) K954700

ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT by Helix Diagnostics, Inc. — Product Code LKJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1995
Date Received
October 12, 1995
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 Helix Diagnostics, Inc.

  • K001900 — ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST (September 11, 2000)
  • K000489 — ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST (April 5, 2000)
  • K980337 — DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM (May 12, 1998)
  • K960091 — ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT (March 20, 1996)
  • K954723 — ENZYME IMMUNOASSAY ANA SCREENING TEST KIT (December 15, 1995)
  • K952253 — ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT (August 24, 1995)
  • K951850 — ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT (July 18, 1995)
  • K951798 — ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT (July 17, 1995)
  • K940510 — ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT (April 20, 1994)
  • K940588 — ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT (April 20, 1994)

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)