Eonis SCID-SMA kit— 510(k) K203035

Substantially Equivalent

Perkinelmer, Inc.

FDA 510(k) clearance K203035 for Eonis SCID-SMA kit, Substantially Equivalent on 2022-11-09. Applicant: Perkinelmer, Inc.. Device class: 2.

Clearance details

Applicant: Perkinelmer, Inc.
Product code: Code PJI
Device class: Class 2
Regulation: 21 CFR 866.5930
Advisory panel: Immunology
Date received: 2020-10-05
Decision date: 2022-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PJI

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Data sourced from openFDA. This site is unofficial and independent of the FDA.