i-STAT CHEM8+ cartridge with the i-STAT 1 System— 510(k) K210958

Name: FDA 510(k) clearance K210958
Creator: U.S. Food and Drug Administration
Published: 2021-08-13

Substantially Equivalent

Abbott Point of Care, Inc.

FDA 510(k) clearance K210958 for i-STAT CHEM8+ cartridge with the i-STAT 1 System, Substantially Equivalent on 2021-08-13. Applicant: Abbott Point of Care, Inc.. Device class: 2.

Clearance details

Applicant: Abbott Point of Care, Inc.
Product code: Code CGA
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 2021-03-31
Decision date: 2021-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princton, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CGA

view all

K252488 — ABL90 FLEX PLUS System2026-05-01
K210933 — YSI 2900C Biochemistry Analyzer2024-09-30
K220328 — EasyStat 3002024-07-26
K223179 — Cholestech LDX System2023-09-20
K223755 — i-STAT G cartridge with the i-STAT 1 System2023-09-11

More clearances from Abbott Point of Care, Inc.

view all

K261039 — i-STAT Crea cartridge with the i-STAT 1 System2026-06-26
K253051 — i-STAT hs-TnI cartridge with the i-STAT Alinity System2026-06-11
K244014 — i-STAT CG4+ cartridge with the i-STAT 1 System2025-05-02
K240984 — i-STAT hs-TnI cartridge with the i-STAT 1 System2025-01-03
K230275 — i-STAT CG8+ cartridge with the i-STAT 1 System2023-10-27

Adverse events under product code CGA

product code CGA

Death: 2
Malfunction: 1,816
Total: 1,818

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.