i-STAT hs-TnI cartridge with the i-STAT 1 System— 510(k) K240984

Name: FDA 510(k) clearance K240984
Creator: U.S. Food and Drug Administration
Published: 2025-01-03

Substantially Equivalent

Abbott Point of Care, Inc.

FDA 510(k) clearance K240984 for i-STAT hs-TnI cartridge with the i-STAT 1 System, Substantially Equivalent on 2025-01-03. Applicant: Abbott Point of Care, Inc.. Device class: 2.

Clearance details

Applicant: Abbott Point of Care, Inc.
Product code: Code MMI
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 2024-04-10
Decision date: 2025-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princton, NJ, US

Download summary PDF View on FDA.gov ↗

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K230275 — i-STAT CG8+ cartridge with the i-STAT 1 System2023-10-27
K230285 — i-STAT CG8+ cartridge with the i-STAT 1 System2023-10-27
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Adverse events under product code MMI

product code MMI

Injury: 172
Malfunction: 3,762
Total: 3,934

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.