FDA.report

510(k) K220282

Device
i-STAT PTplus Cartridge with the i-STAT 1 System
Applicant
Abbott Laboratories
510(k) number
K220282
Product code
GJS
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-14
Date received
2022-02-01
Regulation
864.7750
Classification name
Test, Time, Prothrombin
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Melissa Tristani
Address
400 College Rd. E. Princton NJ US 08540 08540

FDA Registration Numbers

Source Documents

510(k) summary PDF

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