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510(k) BK060048

Device
Automated Hemoglobin System
Applicant
HemoCue AB
510(k) number
BK060048
Product code
GKR  
Decision
Substantially Equivalent (SE)
Decision date
2006-10-05
Date received
2006-08-09
Regulation
864.5620
Classification name
System, Hemoglobin, Automated
Medical specialty
510(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
Review panel
510(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
Clearance type
510(k) Traditio
Third party reviewed
No

Other 510(k) Records For Product Code GKR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K201217HemoCue Hb 301 SystemHemocue AB2020-08-04
K200909Hemo Control (optional Add Pack Hemo Control DM)Ekf-Diagnostic GmbH2020-06-12
K181751HemoCue Hb 801 SystemHemocue AB2019-02-01
K182298hemochroma PLUS SystemImmunostics Inc.,2018-11-16
K172173DiaSpect Tm, DiaSpect Tm CuvettesEkf-Diagnostic GmbH2018-04-06
K163465hemochroma PLUS SystemImmunostics Inc.,2017-09-08
K122553MISSION PLUS HB HEMOGLOBIN TESTING SYSTEMACON Laboratories, Inc.2013-08-05
K121752AVIE TOTAL HB TEST SYSTEMMec Dynamics Corp2013-01-07
K110393EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE WEkf-Diagnostic GmbH2011-03-04
K090093STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEMStanbio Laboratory2009-06-10
K081719STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEMStanbio Laboratory2008-07-18
K061047HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801Hemocue AB2006-06-08
K041234HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEMHemocue, Inc.2004-06-10
K032482STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEMStanbio Laboratory2003-10-24
K031898EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEMEkf Diagnostic GmbH2003-09-24

Legacy Summary#

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FDA Review#

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