JHF — Colorimetric Method, Lecithin/Sphingomyelin Ratio Class II
FDA product code JHF covers "Colorimetric Method, Lecithin/Sphingomyelin Ratio", a Class II medical device regulated under 21 CFR 862.1455. 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
- JHF
- Device Class
- Class II
- Regulation Number
- 862.1455
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No