510(k) K253658

STA Satellite Max® by Diagnostica Stago, Inc. — Product Code JPA

K253658 is an FDA 510(k) premarket notification submitted by Diagnostica Stago, Inc. for the device "STA Satellite Max®". The FDA issued a decision of Substantially Equivalent on April 27, 2026. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Diagnostica Stago, Inc. has at least 10 other 510(k) clearances on record.