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510(k) K150819

Triglycerides by Randox Laboratories Limited — Product Code CDT

K150819 is an FDA 510(k) premarket notification submitted by Randox Laboratories Limited for the device "Triglycerides". The FDA issued a decision of Substantially Equivalent on August 6, 2015. The device falls under product code CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides), a Class I device regulated under 21 CFR 862.1705. Randox Laboratories Limited has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2015
Date Received
March 27, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Device Class
Class I
Regulation Number
862.1705
Review Panel
CH
Submission Type

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  • K220451 — Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT (October 5, 2023)
  • K162275 — Randox RX Daytona Plus Alkaline Phosphatase (ALP) (April 21, 2017)
  • K161691 — Direct LDL Cholesterol (LDL) (March 20, 2017)
  • K152343 — Direct Bilirubin (February 16, 2016)
  • K152344 — Total Bilirubin (January 28, 2016)
  • 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 CDT

  • K133067 — ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT (November 22, 2013)
  • K130332 — VITROS CHEMISTRY PRODUCTS TRIG SLIDES (May 31, 2013)
  • K113830 — VANTERA CLINICAL ANALYZER (August 30, 2012)
  • K102993 — ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL (May 19, 2011)
  • K063804 — OLYMPUS TRIGLYCERIDE TEST SYSTEM (March 23, 2007)
  • K043546 — DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE (January 18, 2005)
  • K034000 — VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR (March 10, 2004)
  • K020488 — CARESIDE TRGLYCERIDE (April 15, 2002)
  • K010871 — TGL FLEX REAGENT CARTRIDGE (July 9, 2001)
  • K993466 — WAKO L-TYPE TRIGLYCERIDE TEST (November 9, 1999)

FDA data resources