Triglyceride Reagent Set
FDA 510(k) K821205 · Omega Medical Electronics
510(k) numberK821205
Submission
- Device name
- Triglyceride Reagent Set
- Applicant
- Omega Medical Electronics
Mchenry, IL, US - Received
- April 27, 1982
- Decision date
- July 20, 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 |
|---|---|---|
| K823691 | Phosphorus Reagent SetCEO · Traditional | 01/07/1983SE |
| K821212 | Urea Nitrogen Reagent SetCDW · Traditional | 07/22/1982SE |
| K821206 | Sgpt-Uv Reagent SetCKA · Traditional | 07/22/1982SE |
| K821204 | Glucose(Enzymatic) Reagent SetCGA · Traditional | 07/22/1982SE |
| K821208 | Sgot-Uv Reagent SetCIT · Traditional | 07/20/1982SE |
| K821201 | Ldh-Uv Reagent SetCFJ · Traditional | 07/20/1982SE |
| K821209 | Sgot Reagent SetCIQ · Traditional | 07/14/1982SE |
| K821207 | SGPT Reagent SetCKD · Traditional | 07/14/1982SE |
| K821213 | Uric Acid Reagent SetCDH · Traditional | 07/13/1982SE |
| K821210 | Serum Total Protein Reagent SetCEK · Traditional | 07/13/1982SE |
Questions and answers
When was Triglyceride Reagent Set cleared by the FDA?
Triglyceride Reagent Set (K821205) received a 510(k) decision of Substantially Equivalent on July 20, 1982, 84 days after the submission was received.
What is the product code of K821205?
The FDA product code is CDT – Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, a Class I (low risk) device regulated under 21 CFR 862.1705.