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510(k) K823709

TRIGLYCERIDE REAGENT (UV) by Gilford Diagnostics — Product Code CDT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1983
Date Received
December 9, 1982
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

Other clearances by Gilford Diagnostics

  • K832094 — BILIRUBIN CALIBRATORS & CONTROL (August 11, 1983)
  • K831843 — GILCHEM TOTAL BILIRUBIN REAGENT (July 18, 1983)
  • K831844 — DIRECT BILIRUBIN REAGENT (July 18, 1983)
  • K822739 — AHBD (October 18, 1982)
  • K822334 — BILIRUBIN CALIBRATORS (September 2, 1982)
  • K822289 — CO2/CI STANDARDS (August 24, 1982)
  • K822149 — GILCHEM Y-GT REAGENT (August 12, 1982)
  • K821719 — AMMONIA REAGENT (June 24, 1982)
  • K820975 — GILCHEM ACID PHOSPHATASE REAGENT (April 26, 1982)
  • K820976 — GIL CHEM MAGNESIUM REAGENT (April 26, 1982)

Other clearances for product code CDT

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  • 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)