510(k) Report

Devices descending from K853717

2 later devices reach Allegro TM HS-TSH Immunoassay System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990658Thyrochek One-Step Whole Blood Rapid TSH AssayLittle Nell Labs, Inc.19991—
+2K030912Thyro TestThryotec200301