510(k) Report

Devices descending from K931786

30 later devices reach Ace Clinical Chemistry System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131975Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total Iron Reagent, Ace LDH-L…Alfa Wassermann Diagnostic Technologies, Inc.20130—
+1K131351Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast ReagentAlfa Wassermann Diagnostic Technologies, LLC201301
+1K123953Ace Carbon Dioxide Reagent, Ace Direct Biliubin Reagent, Ace Total Bilirubin Reagent…Alfa Wassermann Diagnostic Technologies, Inc.20130—
+1K113437Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace…Alfa Wassermann Diagnostic Technologies, Inc.20121—
+1K113382Ace Alt ReagentAlfa Wassermann201221
+1K113374Ace Albumin Reagent Ace Total Protein Reagent Ace Calcium-Arsenazo Reagent Ace…Alfa Wassermann Diagnostic Technologies, Inc.20121—
+1K113436Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace LDH-L ReagentAlfa Wassermann20121—
+1K113262Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent-C, Ace-Trislycerides ReagentAlfa Wassermann Diagnostic Technologies, Inc.20121—
+1K113435Ace Carbon Dioxide (CO2-LC) Reagent, Ace Direct Bilirubin Reagent, Ace Total Bilirubin…Alfa Wassermann20121—
+1K113438Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron Reagent, Ace Lipase…Alfa Wassermann Diagnostic Technologies, Inc.20121—
+1K113253Ace Axcel Clinical Chemistry System,Ace Albumin Reagent,Ace Total Protein Reagent,Ace…Alfa Wassermann Diagnostic Technologies, Inc.20124—
+1K112538Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace Triglycerides ReagentAlfa Wassermann Diagnostic Technologies, Inc.20120—
+1K091413S-Test Cholesterol (Cho), Model RC0009, S-Test HDL Cholesterol (HDL), Model RC0015…Alfa Wassermann, Inc.20092—
+1K091544S-Test Lactate Dehydrogenase (LD), Model RC 0017Alfa Wassermann, Inc.20090—
+1K082226S40 Creatine Kinase (CK)Alfa Wassermann Diagnostic Technologies, Inc.20080—
+1K072143S40 Clinical Analyzer, S Test AlbAlfa Wassermann Diagnostic Technologies, Inc.20080—
+1K080073S-Test Creatinine (Cre)Alfa Wassermann, Inc.20080—
+1K073223S-Test C02Alfa Wassermann Diagnostic Technologies, Inc.20080—
+1K072142S40 Clinical Analyzer, S Test Alp, S Test Amylase, S Test AstAlfa Wassermann Diagnostic Technologies, Inc.20080—
+1K072140S40 Clinical Analyzer, S Test Bil, S Test Bun, S Test GluAlfa Wassermann Diagnostic Technologies, Inc.20081—
+1K072141S40 Clinical Analyzer, S Test IP, S Test UAAlfa Wassermann Diagnostic Technologies, Inc.20080—
+1K072356S-Test CAAlfa Wassermann Diagnostic Technologies, Inc.20080—
+2K131488Ace Albumin Reagent, Ace Total Protein Reagent, Ace Calcium-Arsenazo Reagent and Ace…Alfa Wassermann Diagnostics Technologies, LLC20130—
+2K131515Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann20130—
+2K123018Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective Electrode…Alfa Wassermann Diagnostic Technologies, Inc.20130—
+2K122757Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace Triglycerides ReagentAlfa Wassermann Diagnostic Technologies, Inc.20120—
+2K122302Ace Magnesium RegentAlfa Wassermann Diagnostics Technologies, LLC20120—
+2K113809Hitachi Clinical Analyzer S Test Regent Cartridge C-Reactive Protein (CRP)Hitachi Chemical Diagnostics, Inc.20120—
+2K120369Hitachi Clinical Analyzer S Test Reagent Cartridge Glucose (Glu)Hitachi Chemical Diagnostics, Inc.20120—
+2K111753Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and…Hitachi Chemical Diagnostics, Inc.20110—