OYL — Tryptase Assay System Class II
FDA product code OYL covers "Tryptase Assay System", a Class II medical device regulated under 21 CFR 866.5760. Submissions are reviewed by the Immunology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OYL
- Device Class
- Class II
- Regulation Number
- 866.5760
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Definition
An in vitro diagnostic device intended as an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis in conjunction with other clinical and laboratory findings.