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510(k) K210801

AXINON® LDL-p Test System by Numares AG — Product Code MRR

K210801 is an FDA 510(k) premarket notification submitted by Numares AG for the device "AXINON® LDL-p Test System". The FDA issued a decision of Substantially Equivalent on July 19, 2023. The device falls under product code MRR (System, Test, Low Density, Lipoprotein), a Class I device regulated under 21 CFR 862.1475.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2023
Date Received
March 17, 2021
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 for product code MRR

  • K241800 — Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) (July 26, 2024)
  • 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)
  • K063841 — NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS (July 23, 2008)
  • 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