FDA 510(k) K191360 i-STAT CHEM8+ Cartridge with the i-STAT 1 System
FDA 510(k) K191360 i-STAT CHEM8+ Cartridge with the i-STAT 1 System
510(K) Number: K191360
Device Name: i-STAT CHEM8+ cartridge with the i-STAT 1 System
Manufacturer: Abbott Point of Care, Inc.
Device Classification Name: Electrode, Ion Specific, Calcium
Regulation Number: 862.1145
Classification Product Code: JFP
Date Received: 05/21/2019
Decision Date: 02/14/2020
Regulation Medical Specialty: Clinical Chemistry
Total pages: 6276
Fully redacted pages: 2509
Content pages: 3767
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