Product code GKH— Hematology

FDA has cleared 14 devices under product code GKH between 1977 and 2010, filed by 12 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 20101 clearance
• 20041 clearance
• 20022 clearances
• 19941 clearance
• 19921 clearance
• 19901 clearance
• 19881 clearance
• 19851 clearance
• 19842 clearances
• 19821 clearance
• 19791 clearance
• 19771 clearance

• Immunicon Corp.2 clearances
• Abbott Diagnostics2 clearances
• Veridex, LLC1 clearance
• Toa Medical Electronics USA, Inc.1 clearance
• Royco Instruments1 clearance
• R&D Systems, Inc.1 clearance
• Ortho Diagnostics, Inc.1 clearance
• Innovative Medical Systems, Inc.1 clearance
• Coulter Electronics, Inc.1 clearance
• Coulter Corp.1 clearance

• K100684 — CELLTRACKS AUTOPREP SYSTEM MODEL:9541Veridex, LLC·2010-08-26
• K040077 — IMMUNICON CELLTRACKS AUTOPREP SYSTEMImmunicon Corp.·2004-03-12
• K022512 — CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518Immunicon Corp.·2002-09-30
• K021150 — COULTER CELLPREPBeckman Coulter, Inc.·2002-06-11
• K935953 — COULTER MULTI Q PREPCoulter Corp.·1994-03-11
• K923530 — COULTER MULTI-Q-PREPCoulter Electronics, Inc.·1992-10-14
• K904795 — FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic·1990-12-31
• K882767 — SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEMToa Medical Electronics USA, Inc.·1988-07-18
• K852373 — AD150, AUTOMATED HEMATOLOGY DILUTORAbbott Diagnostics·1985-07-05
• K842747 — HYCEL DILUTOR, VARIOUS MODELS/MULTIR&D Systems, Inc.·1984-10-01
• K842446 — DILU-MATIC 140Abbott Diagnostics·1984-09-06
• K823522 — DILULAB 230Innovative Medical Systems, Inc.·1982-12-28
• K791644 — ROYCO MODEL 371 SUPER DILUTORRoyco Instruments·1979-09-19
• K761137 — MICROSAMPLE BLOOD COLLECTION DEVICEOrtho Diagnostics, Inc.·1977-02-07