FDA.report

510(k) K253658

Device
STA Satellite Max®
Applicant
Diagnostica Stago, Inc.
510(k) number
K253658
Product code
JPA
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-27
Date received
2025-11-20
Regulation
864.5425
Classification name
System, Multipurpose For In Vitro Coagulation Studies
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Louise Sigismondi
Address
Five Century Dr., Suite 200. Parsippany NJ US 07054 07054

FDA Registration Numbers

Source Documents

510(k) summary PDF

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