Eonis SCID-SMA Kit

by Perkinelmer, Inc. 510(k)

Active United States

510(k) DEN200044

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA De NovoDENG De Novo granted · Direct	NumberDEN200044	Date9 Nov 2022Decided	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA De Novo Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: DEN200044
FDA Product Code: QUE

Device Class: Class II
Regulation: 21 CFR Part 866.5980
Advisory Committee: Immunology
FDA Decision: DENG De Novo granted

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