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510(k) K903897

TRIGLYCERIDES REAGENT GPO 5 X CONC. by Trace Scientific , Ltd. — Product Code CDT

K903897 is an FDA 510(k) premarket notification submitted by Trace Scientific , Ltd. for the device "TRIGLYCERIDES REAGENT GPO 5 X CONC.". The FDA issued a decision of Substantially Equivalent on October 1, 1990. The device falls under product code CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides), a Class I device regulated under 21 CFR 862.1705. Trace Scientific , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1990
Date Received
August 23, 1990
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 Trace Scientific , Ltd.

  • K982121 — ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT (September 17, 1998)
  • K981123 — UREA (April 24, 1998)
  • K962890 — CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) (September 27, 1996)
  • K961114 — AST INCORPORATING DST (May 23, 1996)
  • K961123 — ALT INCORPORATING DST (April 25, 1996)
  • K952488 — TRACE COBAS MIRA RANGE (October 13, 1995)
  • K932713 — TRACE TRANSFERRIN REAGENT (September 30, 1993)
  • K923322 — TRACE ALBUMIN-MR REAGENT (September 11, 1992)
  • K914731 — TRACE GAMMA GT-SS REAGENT (November 19, 1991)
  • K911866 — TRACE TOTAL/DIRECT BILIRUBIN REAGENT (July 17, 1991)

Other clearances for product code CDT

  • K150819 — Triglycerides (August 6, 2015)
  • 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)

FDA data resources