Home / 510(k) Clearances / K042837

510(k) K042837

LIQUICHEK ELEVATED CRP CONTROL by Bio-Rad — Product Code JJX

K042837 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "LIQUICHEK ELEVATED CRP CONTROL". The FDA issued a decision of Substantially Equivalent on Nov 2, 2004. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Bio-Rad has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 2, 2004
Date Received
Oct 14, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Bio-Rad

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

Other clearances for product code JJX

  • K170678 — Beta-CrossLaps CalCheck 5 (Apr 4, 2017)
  • K162173 — Elecsys CYFRA 21-1 CalCheck 5 (Jan 12, 2017)
  • K162514 — Multichem A1c (Oct 26, 2016)
  • K161874 — Audit MicroControls Linearity DROP LQ Blood Glucose (Aug 10, 2016)
  • K161522 — LIAISON EBV IgM Serum Control Set (Jun 30, 2016)
  • K161526 — LIAISON CMV IgM Serum Control Set (Jun 30, 2016)
  • K161082 — IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration (May 17, 2016)
  • K152117 — Dropper hsCRP High Sensitivity CRP Control (Apr 21, 2016)
  • K151742 — Contour Next Control Solution (Sep 23, 2015)
  • K143687 — ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Ce (Jul 17, 2015)

FDA data resources