Triglycerides Reagent System
FDA 510(k) K843832 · Fermco Biochemics, Inc.
510(k) numberK843832
Submission
- Device name
- Triglycerides Reagent System
- Applicant
- Fermco Biochemics, Inc.
Elk Grove Village, IL, US - Received
- October 1, 1984
- Decision date
- November 27, 1984
- 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
Other 510(k)s with product code CDT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K150819 | TriglyceridesCDT · Traditional | Randox Laboratories Limited | 08/06/2015SE |
| K133067 | Advia Chemistry TRIGLYCERIDES_2 (TRIG_2) ReagentCDT · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/22/2013SE |
| 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 |
More from Dade Behring, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K823106 | Rermco Test Chloride ReagentJFS · Traditional | 11/16/1982SE |
| K822118 | Fermcotest Creatinine Test ReagentCGX · Traditional | 09/30/1982SE |
| K822117 | Fermcotest CO2 ReagnetJFL · Traditional | 09/30/1982SE |
| K810567 | Germco Test R Glucose Test KitCGA · Traditional | 03/13/1981SE |
| K791066 | Glucose God-Pap Trinder Method Test KitCGA · Traditional | 09/04/1979SE |
| K791018 | Fermcotest R Bun Rate Reagent Test KitCDS · Traditional | 07/17/1979SE |
| K781945 | Glucose Oxidase ReagentCGA · Traditional | 01/17/1979SE |
Questions and answers
When was Triglycerides Reagent System cleared by the FDA?
Triglycerides Reagent System (K843832) received a 510(k) decision of Substantially Equivalent on November 27, 1984, 57 days after the submission was received.
What is the product code of K843832?
The FDA product code is CDT – Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, a Class I (low risk) device regulated under 21 CFR 862.1705.