FDA 510(k)

Eonis SCID-SMA kit

K-Number: K203035 · 2022-11-09

Decision Date2022-11-09

Product CodePJI

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

Eonis SCID-SMA kit is the device name listed in this FDA 510(k) record. The listed applicant is Perkinelmer, Inc.. It received FDA 510(k) clearance on 2022-11-09 under 510(k) 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. The listed applicant is Perkinelmer, Inc.. The 510(k) number is K203035.

When did Eonis SCID-SMA kit receive FDA 510(k) clearance?

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

Who is the listed applicant for Eonis SCID-SMA kit?

The FDA 510(k) record lists Perkinelmer, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Perkinelmer, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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