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510(k) K984473

LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205 by Bio-Rad — Product Code LKJ

K984473 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205". The FDA issued a decision of Substantially Equivalent on December 22, 1998. The device falls under product code LKJ (Antinuclear Antibody, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Bio-Rad has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1998
Date Received
December 16, 1998
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 Bio-Rad

  • K171061 — MRSASelect II (December 28, 2017)
  • K122187 — VRESELECT CULTURE MEDIUM (November 6, 2012)
  • K103684 — VRESELECT CULTURE MEDIUM (October 21, 2011)
  • K093678 — PLATELIA ASPERGILLUS EIA MODEL 62793 (January 13, 2011)
  • K100589 — MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS (October 29, 2010)
  • K081362 — PLATELIA LYME IGM (June 26, 2008)
  • K081212 — MRSASELECT - EXTENDED INCUBATION (June 13, 2008)
  • K080012 — PLATELIA LYME IGG ASSAY (May 8, 2008)
  • K070361 — MRSASELECT (September 13, 2007)
  • K060641 — PLATELIA ASPERGILLUS EIA, MODEL 62793 (June 2, 2006)

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