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510(k) K022512

Device
CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518
Applicant
Immunicon Corp.
510(k) number
K022512
Product code
GKH
Decision
Substantially Equivalent (SESE)
Decision date
2002-09-30
Date received
2002-07-30
Regulation
864.5240
Classification name
Apparatus, Automated Blood Cell Diluting
Medical specialty
Hematology
Review panel
Hematology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
PETER SCOTT
Address
3401 Masons Mill Rd. Suite 100 Huntingdon Valley PA US 19006 19006

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GKH#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K100684CELLTRACKS AUTOPREP SYSTEM MODEL:9541Veridex, LLC2010-08-26
K040077IMMUNICON CELLTRACKS AUTOPREP SYSTEMImmunicon Corp.2004-03-12
K021150COULTER CELLPREPBeckman Coulter, Inc.2002-06-11
K935953COULTER MULTI Q PREPCoulter Corp.1994-03-11
K923530COULTER MULTI-Q-PREPCoulter Electronics, Inc.1992-10-14
K904795FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic1990-12-31
K882767SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEMToa Medical Electronics USA, Inc.1988-07-18
K852373AD150, AUTOMATED HEMATOLOGY DILUTORAbbott Diagnostics1985-07-05
K842747HYCEL DILUTOR, VARIOUS MODELS/MULTIR&D Systems, Inc.1984-10-01
K842446DILU-MATIC 140Abbott Diagnostics1984-09-06
K823522DILULAB 230Innovative Medical Systems, Inc.1982-12-28
K791644ROYCO MODEL 371 SUPER DILUTORRoyco Instruments1979-09-19
K761137MICROSAMPLE BLOOD COLLECTION DEVICEOrtho Diagnostics, Inc.1977-02-07