Dowflow Enzymatic Triglycerides Determ
FDA 510(k) K821315 · The Dow Chemical Co.
510(k) numberK821315
Submission
- Device name
- Dowflow Enzymatic Triglycerides Determ
- Applicant
- The Dow Chemical Co.
Mchenry, IL, US - Received
- May 4, 1982
- Decision date
- May 24, 1982
- 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 |
|---|---|---|
| K823474 | Enzymatic Glucose DeterminationCGA · Traditional | 12/30/1982SE |
| K822154 | Urea Nitrogen (Enzymatic) DeterminationCDN · Traditional | 08/05/1982SE |
| K821536 | Dowflow Alt-Uv DeterminationCKA · Traditional | 06/14/1982SE |
| K820714 | Dow Bilirubin(Direct) DeterminationCIG · Traditional | 04/01/1982SE |
| K820675 | Bilirubin(Total) Determination CTMSCIG · Traditional | 04/01/1982SE |
| K812777 | Direct Iron Reagent SetJIY · Traditional | 10/19/1981SE |
| K811806 | Quick-Chem ColorimeterJJQ · Traditional | 07/15/1981SE |
| K810861 | Creatine Kinase MB Isoenzyme Immuno UVJHW · Traditional | 04/14/1981SE |
| K810727 | Ast-Uv (Plp-Activated) DeterminationCIT · Traditional | 03/31/1981SE |
| K801501 | UV Uric Acid StandardsJIS · Traditional | 09/26/1980SE |
Questions and answers
When was Dowflow Enzymatic Triglycerides Determ cleared by the FDA?
Dowflow Enzymatic Triglycerides Determ (K821315) received a 510(k) decision of Substantially Equivalent on May 24, 1982, 20 days after the submission was received.
What is the product code of K821315?
The FDA product code is CDT – Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, a Class I (low risk) device regulated under 21 CFR 862.1705.