Horizon Diagnostics Triglycerides-Gpo Reagent
FDA 510(k) K933722 · Horizon Diagnostics, Inc.
510(k) numberK933722
Submission
- Device name
- Horizon Diagnostics Triglycerides-Gpo Reagent
- Applicant
- Horizon Diagnostics, Inc.
Ann Arbor, MI, US - Received
- August 2, 1993
- Decision date
- June 13, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K971566 | Creatine Kinase-Mb Reagent SetCGS · Traditional | 07/14/1997SE |
| K935712 | Iron/Tibc ReagentJIY · Traditional | 09/20/1995SE |
| K930678 | AmylaseJFJ · Traditional | 04/06/1994SE |
| K934533 | BUN-300/BUN-500 Urea Nitrogen ReagentCDQ · Traditional | 11/26/1993SE |
| K930679 | Direct BilirubinCIG · Traditional | 06/29/1993SE |
| K930074 | In-Vitro Diagnostic Reagent SetJGJ · Traditional | 05/11/1993SE |
Questions and answers
When was Horizon Diagnostics Triglycerides-Gpo Reagent cleared by the FDA?
Horizon Diagnostics Triglycerides-Gpo Reagent (K933722) received a 510(k) decision of Substantially Equivalent on June 13, 1996, 1,046 days after the submission was received.
What is the product code of K933722?
The FDA product code is CDT – Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, a Class I (low risk) device regulated under 21 CFR 862.1705.