510(k) Report

Devices descending from K862813

2 later devices reach FSH Maiaclone Immunoradiometric Assay Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032002Fertell Female Fertility TestGenosis, Inc.20031—
+2K070484Quantrx Female Fertility TestQuantrx Biomedical Corporation20070—