Clinistat Triglycerides Reagent Test
FDA 510(k) K885134 · Heraeus Kulzer, Inc.
510(k) numberK885134
Submission
- Device name
- Clinistat Triglycerides Reagent Test
- Applicant
- Heraeus Kulzer, Inc.
Elkhart, IN, US - Received
- December 12, 1988
- Decision date
- February 10, 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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Questions and answers
When was Clinistat Triglycerides Reagent Test cleared by the FDA?
Clinistat Triglycerides Reagent Test (K885134) received a 510(k) decision of Substantially Equivalent on February 10, 1989, 60 days after the submission was received.
What is the product code of K885134?
The FDA product code is JGY – Colorimetric Method, Triglycerides, a Class I (low risk) device regulated under 21 CFR 862.1705.