i-STAT Crea cartridge with the i-STAT 1 System
K-Number: K261039 · 2026-06-26
Device Summary
Frequently Asked Questions
What is the i-STAT Crea cartridge with the i-STAT 1 System?
i-STAT Crea cartridge with the i-STAT 1 System is a medical device that received FDA 510(k) clearance on 2026-06-26. The listed applicant is Abbott Point of Care, Inc.. The 510(k) number is K261039.
When did i-STAT Crea cartridge with the i-STAT 1 System receive FDA 510(k) clearance?
i-STAT Crea cartridge with the i-STAT 1 System received FDA 510(k) clearance on 2026-06-26, under 510(k) number K261039.
Who is the listed applicant for i-STAT Crea cartridge with the i-STAT 1 System?
The FDA 510(k) record lists Abbott Point of Care, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for i-STAT Crea cartridge with the i-STAT 1 System?
The FDA product code for i-STAT Crea cartridge with the i-STAT 1 System is CGL.
Other records listing Abbott Point of Care, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: CGL)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.