OYL · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5760
Classification
FDA Product Code
OYL
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.5760
Review panel
IM
Medical specialty
Immunology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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.