Source document or public record
FDA 510(k) K203035 — Eonis SCID-SMA kit
FDA 510(k) index record K203035. Device: Eonis SCID-SMA kit. Applicant as listed: Perkinelmer, Inc.. Decision date: 2022-11-09.
Source
"device_name": "Eonis SCID-SMA kit"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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2026-10-20
2026-10-20
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FDA 510(k) public index record K203035.
Device name: Eonis SCID-SMA kit. Applicant as listed: Perkinelmer, Inc..
Decision date: 2022-11-09. Decision wording: Substantially Equivalent.
Product code: PJI. Regulation: 21 CFR 866.5930. Medical specialty: Immunology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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