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510(k) K024218

LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 by Bio-Rad — Product Code LKJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2003
Date Received
December 23, 2002
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

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  • K060641 — PLATELIA ASPERGILLUS EIA, MODEL 62793 (June 2, 2006)

Other clearances for product code LKJ

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  • 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)
  • K024223 — LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116 (January 13, 2003)