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510(k) K161691

Direct LDL Cholesterol (LDL) by Randox Laboratories Limited — Product Code MRR

K161691 is an FDA 510(k) premarket notification submitted by Randox Laboratories Limited for the device "Direct LDL Cholesterol (LDL)". The FDA issued a decision of Substantially Equivalent on March 20, 2017. The device falls under product code MRR (System, Test, Low Density, Lipoprotein), a Class I device regulated under 21 CFR 862.1475. Randox Laboratories Limited has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2017
Date Received
June 20, 2016
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 Randox Laboratories Limited

  • K250741 — Evidence MultiSTAT DOA Urine MultiPlex (January 23, 2026)
  • K220451 — Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT (October 5, 2023)
  • K221550 — Evidence MultiSTAT DOA Urine MultiPlex (October 5, 2023)
  • K162275 — Randox RX Daytona Plus Alkaline Phosphatase (ALP) (April 21, 2017)
  • K152343 — Direct Bilirubin (February 16, 2016)
  • K152344 — Total Bilirubin (January 28, 2016)
  • K150819 — Triglycerides (August 6, 2015)
  • K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (December 8, 2014)
  • K142181 — RANDOX ALDOLASE CALIBRATION SERUM (September 18, 2014)
  • K140522 — RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY P (May 22, 2014)

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)
  • 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