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510(k) K871122

TRIGLYCERIDES DETERMINATION by Biochemical Trade, Inc. — Product Code CDT

K871122 is an FDA 510(k) premarket notification submitted by Biochemical Trade, Inc. for the device "TRIGLYCERIDES DETERMINATION". The FDA issued a decision of Substantially Equivalent on April 7, 1987. The device falls under product code CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides), a Class I device regulated under 21 CFR 862.1705. Biochemical Trade, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1987
Date Received
March 20, 1987
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 Biochemical Trade, Inc.

  • K942958 — CREATINE KINASE MB DETERMINATION (UV) (November 21, 1994)
  • K910635 — TOTAL BILIRUBIN REAGENT SET (May 15, 1991)
  • K910296 — PHOSPHORUS (INORGANIC) TEST SYSTEM (February 27, 1991)
  • K905776 — ALBUMIN REAGENT SET (February 26, 1991)
  • K905790 — TOTAL PROTEIN REAGENT SET (February 21, 1991)
  • K905619 — CREATININE (RATE) REAGENT SET (February 13, 1991)
  • K905650 — KINETIC ALKALINE PHOSPHATASE DETERMINATION (February 13, 1991)
  • K905651 — KINETIC AMYLASE DETERMINATION (January 31, 1991)
  • K905649 — GAMMA-GLUTAMYL TRANSFERASE DETERMINATION (January 30, 1991)
  • K905588 — CREATINE KINASE UV REAGENT SET (January 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