Last synced on 14 November 2025 at 11:06 pm

i-STAT hs-TnI cartridge with the i-STAT 1 System

Page Type
Cleared 510(K)
510(k) Number
K240984
510(k) Type
Traditional
Applicant
Abbott Point of Care Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/3/2025
Days to Decision
268 days
Submission Type
Summary

i-STAT hs-TnI cartridge with the i-STAT 1 System

Page Type
Cleared 510(K)
510(k) Number
K240984
510(k) Type
Traditional
Applicant
Abbott Point of Care Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/3/2025
Days to Decision
268 days
Submission Type
Summary