L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase
L-Leucine-4-Nitroanilide (Colorimetric) for Leucine Arylamidase is a clinical chemistry test system that uses a chromogenic substrate to measure leucine aminopeptidase activity in serum, used in the evaluation of hepatobiliary and pancreatic disease. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is JGG, regulated under 21 CFR 862.1460, within the Clinical Chemistry medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- JGG
- Device Class
- FDA class 1
- Regulation Number
- 862.1460
- 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 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.