Source document or public record
FDA 510(k) K193406 — CardioChek Plus Test System; CardioChek Plus Home Test System
FDA 510(k) index record K193406. Device: CardioChek Plus Test System; CardioChek Plus Home Test System. Applicant as listed: Polymer Technology Systems, Inc. D/B/A Pts Diagnostics. Decision date: 2022-02-26.
Source
"device_name": "CardioChek Plus Test System; CardioChek Plus Home Test System"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K193406.
Device name: CardioChek Plus Test System; CardioChek Plus Home Test System. Applicant as listed: Polymer Technology Systems, Inc. D/B/A Pts Diagnostics.
Decision date: 2022-02-26. Decision wording: Substantially Equivalent.
Product code: NBW. Regulation: 21 CFR 862.1345. 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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