510(k) Report

Devices descending from K831342

2 later devices reach Coat-a-Count NO-Extraction Testosterone through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023091ST Aia-Pack Testosterone AssayTosoh Medics, Inc.200203
+1K955102Biodata Testosterone Maia KitBiochem Immunosystems (U.S.), Inc.19960—