Atlas FDA

GKH

14 FDA 510(k) clearances · Product code

73 daysmedian time to decision
90 days90th percentile
14clearances measured

FDA profile

Official device name
Apparatus, Automated Blood Cell Diluting
Device class
Class I (low risk)
Regulation
21 CFR 864.5240
Medical specialty
Hematology
Adverse events (MAUDE)
2001: 1 · 2003: 39 · 2004: 2 · 2005: 4 · 2006: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
CELLTRACKS AUTOPREP SYSTEM MODEL:9541 (K100684)Veridex, LLC2010-08-26
IMMUNICON CELLTRACKS AUTOPREP SYSTEM (K040077)Immunicon Corp.2004-03-12
CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 (K022512)Immunicon Corp.2002-09-30
COULTER CELLPREP (K021150)Beckman Coulter, Inc.2002-06-11
COULTER MULTI Q PREP (K935953)Coulter Corp.1994-03-11
COULTER MULTI-Q-PREP (K923530)Coulter Electronics, Inc.1992-10-14
FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM (K904795)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-12-31
SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM (K882767)Toa Medical Electronics USA, Inc.1988-07-18
AD150, AUTOMATED HEMATOLOGY DILUTOR (K852373)Abbott Diagnostics1985-07-05
HYCEL DILUTOR, VARIOUS MODELS/MULTI (K842747)R&D Systems, Inc.1984-10-01
DILU-MATIC 140 (K842446)Abbott Diagnostics1984-09-06
DILULAB 230 (K823522)Innovative Medical Systems, Inc.1982-12-28
ROYCO MODEL 371 SUPER DILUTOR (K791644)Royco Instruments1979-09-19
MICROSAMPLE BLOOD COLLECTION DEVICE (K761137)Ortho Diagnostics, Inc.1977-02-07

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Every clearance here is in the API, with alerts when new ones post.