510(k) Report

Devices descending from K041408

3 later devices reach Polymedco OC Auto Micro 80 Fob Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200754Hemosure Accu-Reader A100W.H.P.M., Inc.20220—
+1K132167I-Chroma Ifob with I-Chroma ReaderBoditech Med, Inc.20141—
+2K163225AFIAS iFOB with AFIAS-50Immunostics Inc.,20170—