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510(k) K945677

Device
IL682, CO-OXIMETER
Applicant
INSTRUMENTATION LABORATORY CO.
510(k) number
K945677
Product code
GKR  
Decision
Substantially Equivalent (SESE)
Decision date
1995-10-20
Date received
1994-11-18
Regulation
864.5620
Classification name
System, Hemoglobin, Automated
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
WALLIS W CADY
Address
101 Hartwell Ave. Lexington MA US 02421 02421

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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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