i-STAT CG4+ cartridge with the i-STAT 1 System— 510(k) K244014
Substantially EquivalentAbbott Point of Care, Inc.
FDA 510(k) clearance K244014 for i-STAT CG4+ cartridge with the i-STAT 1 System, Substantially Equivalent on 2025-05-02. Applicant: Abbott Point of Care, Inc..
Clearance details
- Applicant
- Abbott Point of Care, Inc.
- Product code
- Code CHL
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Princton, NJ, US
Adverse events under product code CHL
product code CHL- Death
- 20
- Malfunction
- 999
- Total
- 1,019
Source: openFDA MAUDE database, through . 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.