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510(k) K063841

NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS by Liposcience — Product Code MRR

K063841 is an FDA 510(k) premarket notification submitted by Liposcience for the device "NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS". The FDA issued a decision of Substantially Equivalent on July 23, 2008. The device falls under product code MRR (System, Test, Low Density, Lipoprotein), a Class I device regulated under 21 CFR 862.1475. Liposcience has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2008
Date Received
December 26, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Low Density, Lipoprotein
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

Other clearances by Liposcience

  • K133849 — VANTERA CLINICAL ANALYZER (October 22, 2014)
  • K113830 — VANTERA CLINICAL ANALYZER (August 30, 2012)
  • K111516 — NMR LIPOPROFILE (R) TEST AND NMR PROFILER (September 27, 2011)

Other clearances for product code MRR

  • K241800 — Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) (July 26, 2024)
  • K210801 — AXINON® LDL-p Test System (July 19, 2023)
  • K161691 — Direct LDL Cholesterol (LDL) (March 20, 2017)
  • K091333 — S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 (August 3, 2009)
  • K090734 — EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROL (July 17, 2009)
  • K051121 — DIRECT LDL CHOLESTEROL, MODEL L530-60H (August 8, 2005)
  • K043264 — LDL-EX SEIKEN ASSAY KIT (January 26, 2005)
  • K041927 — LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 (November 23, 2004)
  • K041720 — VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND P (August 25, 2004)
  • K040693 — PTS PANELS LDL CHOLESTEROL TEST STRIPS (July 6, 2004)

FDA data resources