i-STAT G3+ cartridge with the i-STAT 1 System— 510(k) K223857
Substantially EquivalentAbbott Point of Care, Inc.
FDA 510(k) clearance K223857 for i-STAT G3+ cartridge with the i-STAT 1 System, Substantially Equivalent on 2023-09-15. Applicant: Abbott Point of Care, Inc.. Device class: 2.
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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Princton, NJ, US
Recent devices under product code CHL
view allMore clearances from Abbott Point of Care, Inc.
view allAdverse 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 →
Recalls naming K223857
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K223857.
Data sourced from openFDA. This site is unofficial and independent of the FDA.