Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Eonis SCID-SMA kit

K-Number: K203035 · 2022-11-09

ApplicantPerkinelmer, Inc.
Decision Date2022-11-09
Product CodePJI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Eonis SCID-SMA kit is a medical device manufactured by Perkinelmer, Inc.. It received FDA 510(k) clearance on 2022-11-09 under approval number K203035. The device is classified under product code PJI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Eonis SCID-SMA kit?

Eonis SCID-SMA kit is a medical device that received FDA 510(k) clearance on 2022-11-09. It is manufactured by Perkinelmer, Inc.. The 510(k) number is K203035.

When was Eonis SCID-SMA kit approved by the FDA?

Eonis SCID-SMA kit received FDA 510(k) clearance on 2022-11-09, under approval number K203035.

What company makes Eonis SCID-SMA kit?

Eonis SCID-SMA kit is manufactured by Perkinelmer, Inc..

What is the FDA product code for Eonis SCID-SMA kit?

The FDA product code for Eonis SCID-SMA kit is PJI.

Other Devices by Perkinelmer, Inc.

K161966PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector K161942PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector DEN180056GSP Neonatal Creatine Kinase - MM kit K190335GSP Neonatal Total Galactose kit K190266NeoLSD MSMS Kit K193103NeoBase 2 Non-derivatized MSMS Kit

View all 8 devices →

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑