Triglycerides Test Kit

FDA 510(k) K895952 · Elite Technology, Inc.

Substantially Equivalent

510(k) numberK895952

Submission

Device name
Triglycerides Test Kit
Applicant
Elite Technology, Inc.
Canada M9w 5p1, CA
Received
October 11, 1989
Decision date
January 11, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CDT – Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Device class
Class I (low risk)
Regulation
21 CFR 862.1705
Specialty
Clinical Chemistry

Other 510(k)s with product code CDT

510(k)DeviceApplicantDecision
K150819TriglyceridesCDT · Traditional Randox Laboratories Limited08/06/2015SE
K133067Advia Chemistry TRIGLYCERIDES_2 (TRIG_2) ReagentCDT · Traditional Siemens Healthcare Diagnostics, Inc.11/22/2013SE
K130332Vitros Chemistry Products Trig SlidesCDT · Special Ortho-Clinical Diagnostics, Inc.05/31/2013SE
K113830Vantera Clinical AnalyzerCDT · Traditional Liposcience08/30/2012SE
K102993Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems Cholesterol SLCDT · Traditional Seppim S.A.S.05/19/2011SE
K063804Olympus Triglyceride Test SystemCDT · Traditional Olympus America, Inc.03/23/2007SE
K043546Dimension RXL Max with Streamlab Analytical Workcell and Sample Transfer ModuleCDT · Special Dade Behring, Inc.01/18/2005SE
K034000Vitalab Triglycerides Reagent and Vitalab CalibratorCDT · Traditional Clinical Data, Inc.03/10/2004SE
K020488Careside TrglycerideCDT · Traditional Careside, Inc.04/15/2002SE
K010871TGL Flex Reagent CartridgeCDT · Traditional Dade Behring, Inc.07/09/2001SE

More from Dade Behring, Inc.

510(k)DeviceDecision
K900733Protein Test for Urine and CSFCEK · Traditional 07/10/1990SE
K901001Uric Acid Test KitKNK · Traditional 05/23/1990SE
K901090Elitech Gamma GT Test KitJPZ · Traditional 03/29/1990SE
K895951Cholesterol Test KitCHH · Traditional 02/16/1990SE

Questions and answers

When was Triglycerides Test Kit cleared by the FDA?

Triglycerides Test Kit (K895952) received a 510(k) decision of Substantially Equivalent on January 11, 1990, 92 days after the submission was received.

What is the product code of K895952?

The FDA product code is CDT – Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, a Class I (low risk) device regulated under 21 CFR 862.1705.