Ultrachem Tri-Es
FDA 510(k) K821875 · Harleco Diagnostics
510(k) numberK821875
Submission
- Device name
- Ultrachem Tri-Es
- Applicant
- Harleco Diagnostics
Mchenry, IL, US - Received
- June 25, 1982
- Decision date
- July 13, 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 |
|---|---|---|
| K823147 | Uric Acid Standard, 8MG/DL #65078JIS · Traditional | 11/22/1982SE |
| K822852 | Triglyceride CalibratorJIT · Traditional | 10/27/1982SE |
| K822323 | Ultrachem Bun-Uv, 65080 & 65081CDW · Traditional | 09/02/1982SE |
| K821883 | Ultrazyme Plus Ck-ICGS · Traditional | 07/14/1982SE |
| K821882 | Ultrazyme Plus GPTCKA · Traditional | 07/14/1982SE |
| K821881 | Ultrachem CreaCGX · Traditional | 07/14/1982SE |
| K821880 | Ultra Chem AlbCIX · Traditional | 07/14/1982SE |
| K821879 | Ultrachem T.P.CEX · Traditional | 07/14/1982SE |
| K821878 | Ultrazyme Plus LDHCFJ · Traditional | 07/14/1982SE |
| K821877 | Ultrazyme Plus HBDJMK · Traditional | 07/14/1982SE |
Questions and answers
When was Ultrachem Tri-Es cleared by the FDA?
Ultrachem Tri-Es (K821875) received a 510(k) decision of Substantially Equivalent on July 13, 1982, 18 days after the submission was received.
What is the product code of K821875?
The FDA product code is CDT – Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, a Class I (low risk) device regulated under 21 CFR 862.1705.