Source document or public record
FDA 510(k) K230300 — i-STAT CG8+ cartridge with the i-STAT 1 System
FDA 510(k) index record K230300. Device: i-STAT CG8+ cartridge with the i-STAT 1 System. Applicant as listed: Abbott Point of Care, Inc.. Decision date: 2023-10-27.
Source
"device_name": "i-STAT CG8+ cartridge with the i-STAT 1 System"
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 K230300.
Device name: i-STAT CG8+ cartridge with the i-STAT 1 System. Applicant as listed: Abbott Point of Care, Inc..
Decision date: 2023-10-27. Decision wording: Substantially Equivalent.
Product code: JFP. Regulation: 21 CFR 862.1145. 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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