KIW — Kit, Mycoplasma Detection Class I
FDA product code KIW covers "Kit, Mycoplasma Detection", a Class I medical device regulated under 21 CFR 864.2360. Submissions are reviewed by the Hematology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KIW
- Device Class
- Class I
- Regulation Number
- 864.2360
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No