Qualitative Test For HLA, Non-diagnostic

Test, Qualitative, For Hla, Non-diagnostic

Immucor GTI Diagnostics, Inc.

The following data is part of a premarket notification filed by Immucor Gti Diagnostics, Inc. with the FDA for Qualitative Test For Hla, Non-diagnostic.

Pre-market Notification Details

Device IDBK190439
510k NumberBK190439
Device Name:Qualitative Test For HLA, Non-diagnostic
ClassificationTest, Qualitative, For Hla, Non-diagnostic
Applicant Immucor GTI Diagnostics, Inc. 20925 Crossroads Circle Waukesha,  WI  53186
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 CodeMZI  
CFR Regulation Number510(k) Premarket Notification [🔎]
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) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-27
Decision Date2020-01-21

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