510(k) Report

Devices descending from K861255

5 later devices reach Behring Rapignost Total Screen L Urine Test Strips through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061559Acon Urinalysis Reagent StripsAcon Laboratories Co.200601
+1K040703Uristik H Series Reagent Strips for UrinalysisDirui Industrial Co., Ltd.20043—
+2K111999Healgen 11 Reagent Strip for Urinalysis, Healgen 10 Reagent Strip for Urinalysis, and…Healgen Scientific,, LLC201201
+2K082811Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and Uritest-500B Urine AnalyzersUrit Medical Electronic Co., Ltd.20091—
+3K232317UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine…Urit Medical Electronic Co., Ltd.20240—