Eclipse Ica Triglycerides
FDA 510(k) K905601 · Biotope, Inc.
510(k) numberK905601
Submission
- Device name
- Eclipse Ica Triglycerides
- Applicant
- Biotope, Inc.
Redmond, WA, US - Received
- December 13, 1990
- Decision date
- January 17, 1991
- 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 |
|---|---|---|
| K905145 | Eclipse Ica CholesterolCHH · Traditional | 02/26/1991SE |
| K910302 | Eclipse Ica AnalyzerJJQ · Traditional | 02/22/1991SE |
| K910256 | Eclipse Ica TSHJLW · Traditional | 02/22/1991SE |
| K905719 | Eclipse Ica DigoxinDPO · Traditional | 01/17/1991SE |
| K905602 | Eclipse Ica BunCDQ · Traditional | 01/16/1991SE |
| K905144 | Eclipse Ica GlucoseCFR · Traditional | 01/04/1991SE |
Questions and answers
When was Eclipse Ica Triglycerides cleared by the FDA?
Eclipse Ica Triglycerides (K905601) received a 510(k) decision of Substantially Equivalent on January 17, 1991, 35 days after the submission was received.
What is the product code of K905601?
The FDA product code is CDT – Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, a Class I (low risk) device regulated under 21 CFR 862.1705.