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510(k) K113610

ANA-SCREEN WITH MDSS by Bio-Rad Laboratories — Product Code LKJ

K113610 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories for the device "ANA-SCREEN WITH MDSS". The FDA issued a decision of Substantially Equivalent on July 9, 2012. The device falls under product code LKJ (Antinuclear Antibody, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Bio-Rad Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2012
Date Received
December 6, 2011
Clearance Type
Special
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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Other clearances for product code LKJ

  • K210902 — EliA Ro52, EliA Ro60 (July 27, 2022)
  • 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)
  • K024218 — LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 (January 17, 2003)
  • K024232 — LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113 (January 17, 2003)
  • K024223 — LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116 (January 13, 2003)

FDA data resources