FDA-Device2025-09-24Class II
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
Abbott Point Of Care Inc.
Hazard
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Sold states
US Nationwide distribution.
Affected count
8,962,450 units
Manufactured in
400 College Rd E, N/A, Princeton, NJ, United States
Products
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2583-2025Don't want to check this manually?
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