JGG — L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase Class I
FDA product code JGG covers "L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase", a Class I medical device regulated under 21 CFR 862.1460. Submissions are reviewed by the Clinical Chemistry panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JGG
- Device Class
- Class I
- Regulation Number
- 862.1460
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No