Triglycerides Test (500NM)
FDA 510(k) K800551 · Reagents Applications, Inc.
510(k) numberK800551
Submission
- Device name
- Triglycerides Test (500NM)
- Applicant
- Reagents Applications, Inc.
Mchenry, IL, US - Received
- March 10, 1980
- Decision date
- March 25, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K914033 | Cholestech Lipid Monitor Syst, Triglycerides TestJGY · Traditional | Cholestech Corp. | 09/27/1991SE |
| K905226 | Triglyceride (Gpo) Reagent, UniversalJGY · Traditional | Enzyme Technology, Inc. | 12/11/1990SE |
More from Enzyme Technology, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K982056 | Raichem CO2 ReagentKHS · Special | 06/24/1998SE |
| K972853 | Cholesterol Rapid Liquid ReagentCHH · Traditional | 09/24/1997SE |
| K922904 | Rai-Trol Fructosamine Serum Controls I and IIJJX · Traditional | 07/30/1992SE |
| K915191 | Rai-Trol Elevated Lipids ControlJJY · Traditional | 12/18/1991SE |
| K913398 | Raichem(Tm) Creatine Kinase-Mb ReagentCGS · Traditional | 09/25/1991SE |
| K911900 | Raichem Spia C3 ReagentCZW · Traditional | 05/09/1991SE |
| K911899 | Raichem Spia C4 ReagentDBI · Traditional | 05/09/1991SE |
| K911898 | Raichem(Tm) Spia(Tm) Haptoglobin ReagentDAD · Traditional | 05/08/1991SE |
| K905085 | Raichem GGT ReagentJQB · Traditional | 12/20/1990SE |
| K905084 | Raichem Creatine Kinase Reagent, Optimized UVCGS · Traditional | 12/20/1990SE |
Questions and answers
When was Triglycerides Test (500NM) cleared by the FDA?
Triglycerides Test (500NM) (K800551) received a 510(k) decision of Substantially Equivalent on March 25, 1980, 15 days after the submission was received.
What is the product code of K800551?
The FDA product code is JGY – Colorimetric Method, Triglycerides, a Class I (low risk) device regulated under 21 CFR 862.1705.