Source document or public record
FDA 510(k) K213396 — SPIFE A1AT kit
FDA 510(k) index record K213396. Device: SPIFE A1AT kit. Applicant as listed: Helena Laboratories, Corp.. Decision date: 2022-10-13.
Source
"device_name": "SPIFE A1AT 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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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K213396.
Device name: SPIFE A1AT kit. Applicant as listed: Helena Laboratories, Corp..
Decision date: 2022-10-13. Decision wording: Substantially Equivalent.
Product code: OBZ. Regulation: 21 CFR 866.5130. 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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