Fluorometric Method, Triglycerides
Fluorometric Method for Triglycerides is a clinical chemistry test system using fluorescence-based detection to measure triglyceride concentrations in serum or plasma, used in lipid profiling and assessment of cardiovascular disease risk and metabolic disorders. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is JGW, regulated under 21 CFR 862.1705, within the Clinical Chemistry medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- JGW
- Device Class
- FDA class 1
- Regulation Number
- 862.1705
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K872912 | TRIGLYCERIDE (UV) REAGENT | Aug 17, 1987 | Substantially Equivalent | Sigma Chemical Co. |
| K852556 | TDX REA TRIGLYCERIDES | Jul 22, 1985 | Substantially Equivalent | Abbott Laboratories |
| K780439 | PRECIMAT GLYCEROL | Apr 18, 1978 | Substantially Equivalent | Boehringer Mannheim Corp. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.