i-STAT CG4+ Cartridge with the i-STAT 1 System— 510(k) K200492

Clearance details

Applicant

Abbott Point of Care, Inc.

Product code

Code CHL

Device class

Class 2

Regulation

21 CFR 862.1120

Advisory panel

Clinical Chemistry

Date received

2020-02-28

Decision date

2020-04-09

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Princton, NJ, US

• K252207 — ABL90 FLEX PLUS System, safeCLINITUBES2026-04-10
• K244014 — i-STAT CG4+ cartridge with the i-STAT 1 System2025-05-02
• K240998 — ABL90 FLEX PLUS System2024-12-13
• K230285 — i-STAT CG8+ cartridge with the i-STAT 1 System2023-10-27
• K221900 — Stat Profile Prime Plus Analyzer System2023-09-29

• 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
• 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
• K230300 — i-STAT CG8+ cartridge with the i-STAT 1 System2023-10-27

Death

20

Malfunction

999

Total

1,019

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 →