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KRZ — Calibrator For Hemoglobin And Hematocrit Measurement Class II

FDA Device Classification

Classification Details

Product Code
KRZ
Device Class
Class II
Regulation Number
864.8165
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K052101roche diagnosticsC.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1CAugust 26, 2005
K041130clinical diagnostic solutionsCDS HEMATOLOGY CALIBRATOR (CDS CAL)June 10, 2004
K962864alko diagnosticTHB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERSDecember 18, 1996
K951071alko diagnosticALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERSJuly 24, 1995
K902892unipathCELL-DYN CALIBRATORSeptember 10, 1990
K896921reagents applicationsRAICHEM TM HEMOGLOBIN CALIBRATORJanuary 25, 1990
K893984r and d systemsHGB-CAL SET/MULTIPLEAugust 15, 1989
K883850medical specialtiesMSI-CAL 16November 22, 1988
K883703medical specialtiesMSI-CAL 7November 22, 1988
K883851medical specialtiesMSI-CAL 8November 22, 1988
K882600react andHEMOCUE HEMOGLOBIN CALIBRATORJuly 18, 1988
K873832in vitro diagnosticsREAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801November 23, 1987
K871283u. s. diagnosticsCYANMETHEMOGLOBIN STANDARDApril 15, 1987
K854166interscience diagnosticsHEMATOLOGY CALIBRATOR CONTROLMarch 12, 1986
K842668biodiagnostic intlLIQUI-HEME HEMOGLOBIN CALIBRATORSMarch 5, 1985
K843695bd becton dickinson vacutainer systems preanalyticQCA HEMOGLOBIN KITDecember 17, 1984
K840010american dadeDADE HEMATOLOGY CALIBRATOR PLUSApril 19, 1984
K840261streck laboratoriesCAL-CHEX, A HEMATOLOGY CALIBRATORFebruary 21, 1984
K831814united diagnosticsCALIBRATION STANDARD-HEMOGLOBINJuly 28, 1983
K831872bionosticsCALIBRATOR 282July 18, 1983