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510(k) K021150

COULTER CELLPREP by Beckman Coulter, Inc. — Product Code GKH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2002
Date Received
April 10, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Automated Blood Cell Diluting
Device Class
Class I
Regulation Number
864.5240
Review Panel
HE
Submission Type

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Other clearances for product code GKH

  • K100684 — CELLTRACKS AUTOPREP SYSTEM MODEL:9541 (August 26, 2010)
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  • K022512 — CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 (September 30, 2002)
  • K935953 — COULTER MULTI Q PREP (March 11, 1994)
  • K923530 — COULTER MULTI-Q-PREP (October 14, 1992)
  • K904795 — FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM (December 31, 1990)
  • K882767 — SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM (July 18, 1988)
  • K852373 — AD150, AUTOMATED HEMATOLOGY DILUTOR (July 5, 1985)
  • K842747 — HYCEL DILUTOR, VARIOUS MODELS/MULTI (October 1, 1984)
  • K842446 — DILU-MATIC 140 (September 6, 1984)