Triglycerides Liquid Stable Incorporating Dynamic Stabilisation Technology
FDA 510(k) K953971 · Trace America, Inc.
510(k) numberK953971
Submission
- Device name
- Triglycerides Liquid Stable Incorporating Dynamic Stabilisation Technology
- Applicant
- Trace America, Inc.
Miami, FL, US - Received
- August 23, 1995
- Decision date
- April 5, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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
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| K150819 | TriglyceridesCDT · Traditional | Randox Laboratories Limited | 08/06/2015SE |
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| K130332 | Vitros Chemistry Products Trig SlidesCDT · Special | Ortho-Clinical Diagnostics, Inc. | 05/31/2013SE |
| K113830 | Vantera Clinical AnalyzerCDT · Traditional | Liposcience | 08/30/2012SE |
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| K063804 | Olympus Triglyceride Test SystemCDT · Traditional | Olympus America, Inc. | 03/23/2007SE |
| K043546 | Dimension RXL Max with Streamlab Analytical Workcell and Sample Transfer ModuleCDT · Special | Dade Behring, Inc. | 01/18/2005SE |
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| K020488 | Careside TrglycerideCDT · Traditional | Careside, Inc. | 04/15/2002SE |
| K010871 | TGL Flex Reagent CartridgeCDT · Traditional | Dade Behring, Inc. | 07/09/2001SE |
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| K980028 | Alt (GPT) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST)CKA · Traditional | 02/02/1998SE |
| K980030 | Ast )Got) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST)CIT · Traditional | 01/30/1998SE |
| K973869 | Trace Reagent Line for the Cobas MiraCKA · Traditional | 01/07/1998SE |
| K974620 | Ammonia-Incorporating Dynamic Stabilization Technology (DST)JIF · Traditional | 01/02/1998SE |
| K972297 | Amylase-Incorporating Dynamic Stabilization Technology - (DST)JFJ · Traditional | 07/17/1997SE |
| K971485 | Uric Acid - Incorporating Dynamic Stabilization Technology - (DST)CDO · Traditional | 05/27/1997SE |
| K971477 | Urea (Urea Nitrogen) - Incorporating Dynamic Stabilization Technology (DST)CDQ · Traditional | 05/27/1997SE |
| K962723 | Trace HDL Cholesterol - Automated (HomogenLBR · Traditional | 03/13/1997SE |
Questions and answers
When was Triglycerides Liquid Stable Incorporating Dynamic Stabilisation Technology cleared by the FDA?
Triglycerides Liquid Stable Incorporating Dynamic Stabilisation Technology (K953971) received a 510(k) decision of Substantially Equivalent on April 5, 1996, 226 days after the submission was received.
What is the product code of K953971?
The FDA product code is CDT – Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, a Class I (low risk) device regulated under 21 CFR 862.1705.