DeviceClearance

i-STAT CHEM8+ cartridge with the i-STAT 1 System— 510(k) K191298

Substantially Equivalent

Abbott Point of Care, Inc.

FDA 510(k) clearance K191298 for i-STAT CHEM8+ cartridge with the i-STAT 1 System, Substantially Equivalent on 2020-02-07. Applicant: Abbott Point of Care, Inc..

Clearance details

Applicant
Abbott Point of Care, Inc.
Product code
Code JFL
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Princton, NJ, US
Download summary PDFView on FDA.gov ↗

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