Oil Emulsion/Thymolphthalein (Titrimetric), Lipase
The Oil Emulsion/Thymolphthalein Titrimetric Lipase Test is a clinical chemistry device that measures lipase enzyme activity by titrimetric detection of fatty acids released during hydrolysis of an oil emulsion substrate, using thymolphthalein as an indicator, used in the diagnosis of pancreatic disorders including acute pancreatitis. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CFG, regulated under 21 CFR 862.1465, within the Clinical Chemistry medical specialty. No special flags apply to this device.
Research product code CFG in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- CFG
- Device Class
- FDA class 1
- Regulation Number
- 862.1465
- 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 2 510(k) clearances via K numbers.
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.