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GKF — Instrument, Hematocrit, Automated Class II

FDA Device Classification

Classification Details

Product Code
GKF
Device Class
Class II
Regulation Number
864.5600
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K160415instrumentation laboratoryGEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, CarboxyhemoDecember 14, 2016
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K981425nova biomedicalSTAT PROFILE ULTRA A, B, C, D, AND E ANALYZERSMay 12, 1998
K981426nova biomedicalSTAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERSMay 12, 1998
K953519vulcon technologiesMICROSPIN 24November 3, 1995
K915825fisher scientific coMARATHON 6K GENERAL-PURPOSE CENTRIFUGEMarch 11, 1992
K915441fisher scientific coMARATHON 13K/H MICROHEMATOCRIT CENTRIFUGEJanuary 8, 1992
K904336cobe laboratoriesNEW COBE SATURATION/HEMATOCRIT MONITORDecember 27, 1990
K880373smash entIONOMETER E-HK AND ACCESSORIESMarch 17, 1988
K870860arden medical systemsCHEMPRO 1000(TM)April 14, 1987
K864646e.i. dupont de nemours and coSORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGEJanuary 5, 1987
K864039plaza medicalMICROHEMATOCRIT CENTRIFUGEOctober 29, 1986
K802199united states surgical, a division of tyco healthcSTAT-CRIT HEMATOCRIT MEASURING INSTRUFebruary 4, 1981
K781059cutter laboratoriesCUTTER/COMPUR MINI CENTRIFUGEAugust 14, 1978