510(k) Report

Devices descending from K930007

4 later devices reach Immulite TSH Third Generation Control through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990658Thyrochek One-Step Whole Blood Rapid TSH AssayLittle Nell Labs, Inc.19991—
+1K963916Immulite CannabinoidsDiagnostic Products Corp.19970—
+1K960195Thyrochek One-Step Rapid TSH AssayFranklin Diagnostics, Inc.19962—
+2K030912Thyro TestThryotec200301