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Eonis SCID-SMA Kit

DEN200044 Class II Direct
Decision Date
2022-11-09
Sponsor / Applicant
Perkinelmer, Inc.

Technical Specification

510(k) Submission ID DEN200044
Product Code QUE
Medical Specialty / Panel Immunology
Regulation Citation 21 CFR 866.5980
Decision Date 2022-11-09
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Eonis SCID-SMA Kit received FDA 510(k) clearance under submission number DEN200044, sponsored by Perkinelmer, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2022-11-09.

Classification & Regulation

This clearance is catalogued under FDA product code QUE and 21 CFR 866.5980, within the Immunology review panel as a Class II device.