Automated Blood Grouping And Antibody Test Systems

System, Test, Automated Blood Grouping And Antibody

STRATEC Biomedical UK Limited

The following data is part of a premarket notification filed by Stratec Biomedical Uk Limited with the FDA for Automated Blood Grouping And Antibody Test Systems.

Pre-market Notification Details

Device IDBK190434
510k NumberBK190434
Device Name:Automated Blood Grouping And Antibody Test Systems
ClassificationSystem, Test, Automated Blood Grouping And Antibody
Applicant STRATEC Biomedical UK Limited third Ave, Centrum 100 burton Upon Trent Straffordshire,  DE14 2WD,  UK
Contact510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUrl: Unescape('mp_js_orgin_url'), Init: Function(){ If (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, GetCookie: Function(name){ Var Start=document.cookie.indexOf(name+'='); If(start < 0) Return Null; Start=start+name.length+1; Var End=document.cookie.indexOf(';', Start); If(end < 0) End=document.cookie.length; While (document.cookie.charAt(start)==' '){ Start++; } Return Unescape(document.cookie.substring(start,end)); }, SetCookie: Function(name,value,path,domain){ Var Cookie=name+'='+escape(value); If(path)cookie+='; Path='+path; If(domain)cookie+='; Domain='+domain; Var Now=new Date(); Now.setTime(now.getTime()+1000*60*60*24*365); Cookie+='; Expires='+now.toUTCString(); Document.cookie=cookie; }, SwitchLanguage: Function(lang){ If(lang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); Document.body.appendChild(script); } Else If(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); Document.body.appendChild(script); } Return False; }, SwitchToLang: Function(url) { Window.top.location.href=url; } }; Var Addthis_config = {data_track_clickback: True, Ui_508_compliant: True, Services_compact: 'facebook, Twitter, Linkedin, Pinterest_share, Email', Services_exclude: 'print', Image_container: "#user_provided" } ; FDA Home Medical Devices Databases - .pmn { Color: #000000; Width: 900px; Float: Right; Margin: 0px 25px 0px 0px; } .pmn-left { Color: #000000; Float: Left; Width: 610px; Margin: 9px 30px 0px 0; } .pmn-right { Color: #000000; Float: Right; Width: 190px; Margin: 9px 18px 0 0; Padding: 8px 12px 10px 12px; Background-color: #f3f3f3; Border: 1px Solid #b0b0b0; Border-radius: 6px; } .pmn-intro { Margin: 0 0 18px 0; Padding: 5px 12px 12px 12px; Background-color: #e8eff5; Border: 1px Solid #b0b0b0; Border-radius: 6px; } #pmn-form { Table-layout:fixed; Width: 610px; Font-size: 11px; Border: 1px Solid #b0b0b0; } #pmn-form-title{ Padding: 6px 6px 6px 6px; Width: 100%; Background-color: #e8eff5; Border-bottom: 1px Solid #b0b0b0; Margin-top: 0px; } #pmn-form-title-left { Font-size: 13px; Font-weight: Bold; } #pmn-form-title-right { Font-size: 11px; Padding: 0px 0px 0px 300px; } #pmn-results-table { Table-layout:fixed; Width: 610px; Border-color: #b0b0b0; Border-width: 0 0 1px 1px; Border-style: Solid; } #pmn-results-table Th { Padding: 6px 12px; Background-color: #e8eff5; Border-color: #b0b0b0; Border-width: 1px 1px 0 0; Border-style: Solid; Font-size: 12px; } #pmn-results-table Td { Padding: 6px 12px; Border-color: #b0b0b0; Border-width: 1px 1px 0 0; Border-style: Solid; Text-transform: Capitalize; } #pmn-results-table Tr:nth-child(odd) { Background-color: #f3f3f3; } .sort { Float: Right; Margin-top: 5px;} .sort A { Color: #484138; } .sort A:hover { Color: #0f2a8c; }
Correspondent510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUrl: Unescape('mp_js_orgin_url'), Init: Function(){ If (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, GetCookie: Function(name){ Var Start=document.cookie.indexOf(name+'='); If(start < 0) Return Null; Start=start+name.length+1; Var End=document.cookie.indexOf(';', Start); If(end < 0) End=document.cookie.length; While (document.cookie.charAt(start)==' '){ Start++; } Return Unescape(document.cookie.substring(start,end)); }, SetCookie: Function(name,value,path,domain){ Var Cookie=name+'='+escape(value); If(path)cookie+='; Path='+path; If(domain)cookie+='; Domain='+domain; Var Now=new Date(); Now.setTime(now.getTime()+1000*60*60*24*365); Cookie+='; Expires='+now.toUTCString(); Document.cookie=cookie; }, SwitchLanguage: Function(lang){ If(lang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); Document.body.appendChild(script); } Else If(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); Document.body.appendChild(script); } Return False; }, SwitchToLang: Function(url) { Window.top.location.href=url; } }; Var Addthis_config = {data_track_clickback: True, Ui_508_compliant: True, Services_compact: 'facebook, Twitter, Linkedin, Pinterest_share, Email', Services_exclude: 'print', Image_container: "#user_provided" } ; FDA Home Medical Devices Databases - .pmn { Color: #000000; Width: 900px; Float: Right; Margin: 0px 25px 0px 0px; } .pmn-left { Color: #000000; Float: Left; Width: 610px; Margin: 9px 30px 0px 0; } .pmn-right { Color: #000000; Float: Right; Width: 190px; Margin: 9px 18px 0 0; Padding: 8px 12px 10px 12px; Background-color: #f3f3f3; Border: 1px Solid #b0b0b0; Border-radius: 6px; } .pmn-intro { Margin: 0 0 18px 0; Padding: 5px 12px 12px 12px; Background-color: #e8eff5; Border: 1px Solid #b0b0b0; Border-radius: 6px; } #pmn-form { Table-layout:fixed; Width: 610px; Font-size: 11px; Border: 1px Solid #b0b0b0; } #pmn-form-title{ Padding: 6px 6px 6px 6px; Width: 100%; Background-color: #e8eff5; Border-bottom: 1px Solid #b0b0b0; Margin-top: 0px; } #pmn-form-title-left { Font-size: 13px; Font-weight: Bold; } #pmn-form-title-right { Font-size: 11px; Padding: 0px 0px 0px 300px; } #pmn-results-table { Table-layout:fixed; Width: 610px; Border-color: #b0b0b0; Border-width: 0 0 1px 1px; Border-style: Solid; } #pmn-results-table Th { Padding: 6px 12px; Background-color: #e8eff5; Border-color: #b0b0b0; Border-width: 1px 1px 0 0; Border-style: Solid; Font-size: 12px; } #pmn-results-table Td { Padding: 6px 12px; Border-color: #b0b0b0; Border-width: 1px 1px 0 0; Border-style: Solid; Text-transform: Capitalize; } #pmn-results-table Tr:nth-child(odd) { Background-color: #f3f3f3; } .sort { Float: Right; Margin-top: 5px;} .sort A { Color: #484138; } .sort A:hover { Color: #0f2a8c; }
Product CodeKSZ  
CFR Regulation Number864.9175 [🔎]
DecisionSubstantially Equivalent (SE)
Regulation Medical Specialty510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
510k Review Panel510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-19
Decision Date2020-03-10

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