Home / 510(k) Clearances / K933722

510(k) K933722

HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT by Horizon Diagnostics, Inc. — Product Code CDT

K933722 is an FDA 510(k) premarket notification submitted by Horizon Diagnostics, Inc. for the device "HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT". The FDA issued a decision of Substantially Equivalent on June 13, 1996. The device falls under product code CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides), a Class I device regulated under 21 CFR 862.1705. Horizon Diagnostics, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1996
Date Received
August 2, 1993
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 Horizon Diagnostics, Inc.

  • K971566 — CREATINE KINASE-MB REAGENT SET (July 14, 1997)
  • K935712 — IRON/TIBC REAGENT (September 20, 1995)
  • K930678 — AMYLASE (April 6, 1994)
  • K934533 — BUN-300/BUN-500 UREA NITROGEN REAGENT (November 26, 1993)
  • K930679 — DIRECT BILIRUBIN (June 29, 1993)
  • K930074 — IN-VITRO DIAGNOSTIC REAGENT SET (May 11, 1993)

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