FDA.report

510(k) K253188

Device
CoaguChek XS Plus System
Applicant
Roche Diagnostics
510(k) number
K253188
Product code
GJS
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-24
Date received
2025-09-26
Regulation
864.7750
Classification name
Test, Time, Prothrombin
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Todd Matczak
Address
9115 Hague Rd. Indianapolis IN US 46250 46250

FDA Registration Numbers

Source Documents

510(k) summary PDF

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