Triglycerides Reagent Gpo 5 X Conc.
FDA 510(k) K903897 · Trace Scientific , Ltd.
510(k) numberK903897
Submission
- Device name
- Triglycerides Reagent Gpo 5 X Conc.
- Applicant
- Trace Scientific , Ltd.
Clayton, Australia 3168, AU - Received
- August 23, 1990
- Decision date
- October 1, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K102993 | Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems Cholesterol SLCDT · Traditional | Seppim S.A.S. | 05/19/2011SE |
| 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 |
| K034000 | Vitalab Triglycerides Reagent and Vitalab CalibratorCDT · Traditional | Clinical Data, Inc. | 03/10/2004SE |
| 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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| K932713 | Trace Transferrin ReagentDDQ · Traditional | 09/30/1993SE |
| K923322 | Trace Albumin-Mr ReagentCIX · Traditional | 09/11/1992SE |
| K914731 | Trace Gamma Gt-Ss ReagentJQB · Traditional | 11/19/1991SE |
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Questions and answers
When was Triglycerides Reagent Gpo 5 X Conc. cleared by the FDA?
Triglycerides Reagent Gpo 5 X Conc. (K903897) received a 510(k) decision of Substantially Equivalent on October 1, 1990, 39 days after the submission was received.
What is the product code of K903897?
The FDA product code is CDT – Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, a Class I (low risk) device regulated under 21 CFR 862.1705.