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FDA 510(k) K262576 — twiist Loop Algorithm

FDA 510(k) index record K262576. Device: twiist Loop Algorithm. Applicant as listed: Deka Research and Development Corp.. Decision date: 2026-10-15.

OtherU.S. Food and Drug Administration (FDA)2026-10-15

Source

"device_name": "twiist Loop Algorithm"
api.fda.gov · Retrieved 2026-10-27

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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Reviewer

Automated FDA record verification

Published

2026-10-27

Updated

2026-10-27

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professional use

References

FDA 510(k) public index record K262576.

Device name: twiist Loop Algorithm. Applicant as listed: Deka Research and Development Corp..

Decision date: 2026-10-15. Decision wording: Substantially Equivalent.

Product code: QJI. Regulation: 21 CFR 862.1356. Medical specialty: Clinical Chemistry.

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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FDA 510(k) K262576 — twiist Loop Algorithm

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