510(k) Report

Devices descending from K150358

1 later device reach Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250249Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGold Standard Diagnostics, LLC20250—