Eonis SCID-SMA kit

by Perkinelmer, Inc. 510(k)

Active United States

510(k) K203035

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK203035	Date9 Nov 2022Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K203035
FDA Product Code: PJI

Device Class: Class II
Regulation: 21 CFR Part 866.5930
Advisory Committee: Immunology
FDA Decision: SESE Substantially Equivalent

Other devices from Perkinelmer, Inc.

GSP Neonatal Total Galactose kit

Class I
Eonis SCID-SMA Kit

Class II
GSP Neonatal Creatine Kinase - MM kit

Class II
XRpad Digital X-Ray Detector System XRpad2 3025 HWC-M

Class II
XRpad Digital X-Ray Detector System XRpad2 4336 HWC-M

Class II
XRpad Digital X-Ray Detector System XRpad 4336 MED

Class II

See all devices from Perkinelmer, Inc. →