MKA — Kit, Direct Antigen, Negative Control Class I
FDA product code MKA covers "Kit, Direct Antigen, Negative Control", a Class I medical device regulated under 21 CFR 862.1660. Submissions are reviewed by the Clinical Chemistry panel.
Classification Details
- Product Code
- MKA
- Device Class
- Class I
- Regulation Number
- 862.1660
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Clinical Chemistry
- Implant
- No