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..

Clearance details

Applicant: Perkinelmer, Inc.
Product code: Code PJI
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 ↗

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