OYL · Class II · 21 CFR 866.5760

FDA Product Code OYL: Tryptase Assay System

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.

2
Total
1
Cleared
61d
Avg days
2012
Since

FDA 510(k) Cleared Tryptase Assay System Devices (Product Code OYL)

2 devices
1–2 of 2
No devices found for this product code.

About Product Code OYL - Regulatory Context