Cholestech Lipid Monitor Syst, Triglycerides Test
FDA 510(k) K914033 · Cholestech Corp.
510(k) numberK914033
Submission
- Device name
- Cholestech Lipid Monitor Syst, Triglycerides Test
- Applicant
- Cholestech Corp.
Hayward, CA, US - Received
- September 10, 1991
- Decision date
- September 27, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JGY – Colorimetric Method, Triglycerides
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1705
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JGY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K120664 | Piccolo Trglycerides-Capillary Test SystemJGY · Traditional | Abaxis, Inc. | 04/24/2012SE |
| K023639 | Piccolo Triglycerides Test SystemJGY · Traditional | Abaxis, Inc. | 01/24/2003SE |
| K000586 | Bioscanner Triglycerides Test StripsJGY · Traditional | Polymer Technology Systems, Inc. | 07/03/2000SE |
| K991894 | Bioscanner Triglycerides Test StripsJGY · Traditional | Polymer Technology Systems, Inc. | 05/24/2000SE |
| K971005 | TriglyceridesJGY · Traditional | Derma Media Lab., Inc. | 04/21/1997SE |
| K954187 | Triglycerides ReagentJGY · Traditional | Schiapparelli Biosystems, Inc. | 10/23/1995SE |
| K941063 | DNA Triglyceride ProcedureJGY · Traditional | Data Medical Associates, Inc. | 07/20/1994SE |
| K931116 | Il Test(Tm) TriglycerideJGY · Traditional | Instrumentation Laboratory CO | 03/28/1994SE |
| K905226 | Triglyceride (Gpo) Reagent, UniversalJGY · Traditional | Enzyme Technology, Inc. | 12/11/1990SE |
| K902202 | Dma Triglyceride (Gpo) ProcedureJGY · Traditional | Data Medical Associates, Inc. | 07/31/1990SE |
More from Data Medical Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K040579 | Choletech LDX High-Sensitivity C-Reactive Protein (Hs-Crp)DCK · Traditional | 06/18/2004SE |
| K032027 | Cholestech LDX Aspartate Aminotransferase (Ast)CIS · Traditional | 09/05/2003SE |
| K991834 | Cholestech LDX Alanine Aminotransferase (Alt), Model 11-772CKD · Traditional | 09/09/1999SE |
| K972012 | Cholestech Bun/Creatinine Test SystemCDN · Traditional | 07/24/1997SE |
| K954778 | Cholestech LDX SystemLBS · Traditional | 11/24/1995SE |
| K946067 | Total Cholesterol, HDL Cholesterol, Triglycerides and Glucose PanelCHH · Traditional | 02/22/1995SE |
| K946066 | Total Cholesterol, HDL Cholesterol and Glucose PanelCHH · Traditional | 02/22/1995SE |
| K946065 | Total Cholesterolm HDL Cholesterol and Triglycerides PanelCHH · Traditional | 02/22/1995SE |
| K946064 | Total Cholesterol CassetteCHH · Traditional | 02/22/1995SE |
| K946063 | Total Cholesterol and HDL Cholesterol PanelCHH · Traditional | 02/22/1995SE |
Questions and answers
When was Cholestech Lipid Monitor Syst, Triglycerides Test cleared by the FDA?
Cholestech Lipid Monitor Syst, Triglycerides Test (K914033) received a 510(k) decision of Substantially Equivalent on September 27, 1991, 17 days after the submission was received.
What is the product code of K914033?
The FDA product code is JGY – Colorimetric Method, Triglycerides, a Class I (low risk) device regulated under 21 CFR 862.1705.