510(k) Report

Devices descending from K851504

5 later devices reach VDRL Carbon Antigen Test S900500, S900250 & S90010 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173376ASI EvolutionArlington Scientific, Inc. (Asi)20181—
+1K111356Asimanager - atArlington Scientific, Inc.20112—
+2K201438ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution…Arlington Scientific, Inc. (Asi)20200—
+2K150358Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGold Standard Diagnostics20151—
+3K250249Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGold Standard Diagnostics, LLC20250—