Triglyceride (Gpo) Trinder Reagent
FDA 510(k) K894063 · Sigma Diagnostics, Inc.
510(k) numberK894063
Submission
- Device name
- Triglyceride (Gpo) Trinder Reagent
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- June 8, 1989
- Decision date
- September 7, 1989
- 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 |
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| K020109 | Sigma Diagnostics Accuclot la ControlGGC · Traditional | 02/06/2002SE |
| K013549 | Sigma Diagnostics Auto D-Dimer Calibrator, Model A7971DAP · Traditional | 12/26/2001SE |
| K013545 | Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221DAP · Traditional | 11/15/2001SE |
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| K012410 | Infinity Hba Kit, Models 537-A, 537-BLCP · Traditional | 10/26/2001SE |
| K010652 | Sigma Diagnostics Sigma-Cal, Model S2936JIX · Traditional | 03/30/2001SE |
| K010158 | Thrombomax-Hs with Calcium, Model T6540GGO · Traditional | 03/22/2001SE |
| K003267 | Sigma Diagnostics Auto D-Dimer, Model CRS126-ADAP · Traditional | 03/15/2001SE |
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Questions and answers
When was Triglyceride (Gpo) Trinder Reagent cleared by the FDA?
Triglyceride (Gpo) Trinder Reagent (K894063) received a 510(k) decision of Substantially Equivalent on September 7, 1989, 91 days after the submission was received.
What is the product code of K894063?
The FDA product code is JGY – Colorimetric Method, Triglycerides, a Class I (low risk) device regulated under 21 CFR 862.1705.