510(k) Report

Devices descending from K060641

3 later devices reach Platelia Aspergillus Eia, Model 62793 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101407Alpha Histoplasma Antigen Eia Model HAG102Immuno-Mycologics, Inc.20110—
+1K093678Platelia Aspergillus Eia Model 62793Bio-Rad20111—
+2K243496MycoMEIA Aspergillus AssayPearl Diagnostics, Inc.20250—