Bioscanner Triglycerides Test Strips
FDA 510(k) K000586 · Polymer Technology Systems, Inc.
510(k) numberK000586
Submission
- Device name
- Bioscanner Triglycerides Test Strips
- Applicant
- Polymer Technology Systems, Inc.
Indianapolis, IN, US - Received
- February 22, 2000
- Decision date
- July 3, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| K902202 | Dma Triglyceride (Gpo) ProcedureJGY · Traditional | Data Medical Associates, Inc. | 07/31/1990SE |
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| K071507 | PTS Panels Chol+Hdl+Glu Panel Test StripsNBW · Special | 09/10/2007SE |
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Questions and answers
When was Bioscanner Triglycerides Test Strips cleared by the FDA?
Bioscanner Triglycerides Test Strips (K000586) received a 510(k) decision of Substantially Equivalent on July 3, 2000, 132 days after the submission was received.
What is the product code of K000586?
The FDA product code is JGY – Colorimetric Method, Triglycerides, a Class I (low risk) device regulated under 21 CFR 862.1705.