510(k) Report

Devices descending from K001552

3 later devices reach Trepchek Treponemal Antibody Eia through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102400Syphilis Health CheckDiagnostics Direct, LLC20110—
+1K063866Bioplex 2200 Syphilis Igg Kit on the Bioplex 2200 Multi-Analyte Detection SystemBio-Rad Laboratories200713
+2K120439Bioplex 2200 Ebv Igg and Syphilis IggBio-Rad Laboratories, Inc.20120—