Triglyceride C-37 Rapid Stat Kit
FDA 510(k) K780825 · Pierce Chemical Co.
510(k) numberK780825
Submission
- Device name
- Triglyceride C-37 Rapid Stat Kit
- Applicant
- Pierce Chemical Co.
Mchenry, IL, US - Received
- May 19, 1978
- Decision date
- May 26, 1978
- 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 |
|---|---|---|
| K895661 | Glycotest II Glyhb Assay KitLCP · Traditional | 12/07/1989SE |
| K831837 | Clinovative II Diagnostic KitLCP · Traditional | 08/01/1983SE |
| K821360 | Glyco-Gel Test KitLCP · Traditional | 06/02/1982SE |
| K820279 | Glyco-Gel Test KitLCP · Traditional | 04/08/1982SE |
| K781897 | Stat Kit, MicroproteinCEK · Traditional | 01/10/1979SE |
| K780827 | Uric Acid Rapid Stat KitKNK · Traditional | 06/13/1978SE |
| K780826 | Bilirubin Rapid Stat KitCIG · Traditional | 05/26/1978SE |
| K780512 | Auto/Stat KitCGA · Traditional | 05/03/1978SE |
| K780331 | Cholesterol Rapid Slat Kit HDLCHH · Traditional | 04/06/1978SE |
Questions and answers
When was Triglyceride C-37 Rapid Stat Kit cleared by the FDA?
Triglyceride C-37 Rapid Stat Kit (K780825) received a 510(k) decision of Substantially Equivalent on May 26, 1978, 7 days after the submission was received.
What is the product code of K780825?
The FDA product code is JGY – Colorimetric Method, Triglycerides, a Class I (low risk) device regulated under 21 CFR 862.1705.