510(k) Report

Devices descending from K052133

8 later devices reach Immunoscan RA Anti-CCP Test System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093908CcpointEuro-Diagnostica AB20100—
+1K092399Anti-Mutated Citrullinated Vimentin EiaOrgentec Diagnostika GmbH20100—
+1K091657Immunoscan CcplusEuro-Diagnostica AB200901
+1K081338Roche Elecsys Anti-CCP Immunoassay, Roche Elecsys Precicontrol Anti-CCPRoche Diagnostics200842
+2K121895Elecsys HSV-2 Igg ImmunoassayRoche Diagnostics20121—
+2K120625Elecsys HSV-1 Igg Immunoassay Elecsys Precicontrol HSVRoche Diagnostics20121—
+3K220923Elecsys HSV-1 IgG (08948844160)Roche Diagnostics20220—
+3K220924Elecsys HSV-2 IgG (08948887160)Roche Diagnostics20220—