NAL — Test, Immunoassay, Biosensor, Hcg Class II
FDA product code NAL covers "Test, Immunoassay, Biosensor, Hcg", a Class II medical device regulated under 21 CFR 862.1155. 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
- NAL
- Device Class
- Class II
- Regulation Number
- 862.1155
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No