510(k) Report

Devices descending from K811832

24 later devices reach Precinorm U & Precipath U Human Serum through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992900Precinorm Universal and Precipath Universal Control SeraRoche Diagnostics Corp.199918—
+1K993360Precinorm Universal Plus and Precipath Universal Plus Control SeraRoche Diagnostics Corp.19994—
+2K042389Modification to Precinorm Universal Plus and Precipath Universal Plus Control SeraRoche Diagnostics Corp.20043—
+2K041227Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control SeraRoche Diagnostics Corp.200417—
+3K153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech…Elitechgroup20160—
+3K151552ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical…Elitechgroup20150—
+3K132399Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and Elitrol II, Urine…Elitechgroup20140—
+3K130765Elitech Clinical Systems Elical 2; Elitech Clinical Systems Elitrol I, Elitech Clinical…Elitechgroup20130—
+3K122858Eltech Chinical System Amylase SL Elitech Clinical Systems ELICAL2 Eltech Clinical…Elitechgroup20120—
+3K122083Elitech Clinical Systems CK Nac SLElitechgroup20121—
+3K103376Elitech Clinical Systems Creatinne Pap SL Model CRSL-0250, Clitech Clinical Systems…Seppim S.A.S.20110—
+3K110780Elitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical Systems Elical 2, Elitech…Elitechgroup20110—
+3K103747Elitech Clincal Systems Cholesterol HDL SL 2G, HDL 2G Calibrator, LDL SL 2G, LDL 2G…Elitechgroup Seppim S.A.S.20110—
+3K112029Elitech Clinical Systems Elical 2, Elitech Clinical Systems Elitrol I, Elitech Clinical…Elitechgroup20110—
+3K110830Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin; Elitech…Elitechgroup201101
+3K102993Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems Cholesterol SLSeppim S.A.S.20110—
+3K100263Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsSeppim S.A.S.20110—
+3K102647Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and Elitrol II/Ast/Got 4+1…Elitechgroup Vital Scientific BV201104
+3K100525Elitech Clinical Systems Glucose Pap SL Elitech Clinical Systems Elical 2, Elitech…Seppim S.A.S.201004
+3K093883Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II, Model Assl-0250…Seppim S.A.S.20100—
+3K102016Precicontrol Clinchem Multi 1 and 2Roche Diagnostics20101—
+3K080485Aspartate Amino Transferase (Ast/Sgot) Test System, Asat (Got) FSDiasys Diagnostics Systems GmbH20080—
+4K141265Elitech Clinical Systems Envoy 500 CK Reagent KitElitechgroup20140—
+4K133330C.F.a.S. Proteins, C.F.a.S. Pac, Precicontrol Clinchem Multi 1 & 2, Precinorm Protein &…Roche Diagnostics20130—