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510(k) K022512

CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 by Immunicon Corp. — Product Code GKH

K022512 is an FDA 510(k) premarket notification submitted by Immunicon Corp. for the device "CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518". The FDA issued a decision of Substantially Equivalent on September 30, 2002. The device falls under product code GKH (Apparatus, Automated Blood Cell Diluting), a Class I device regulated under 21 CFR 864.5240. Immunicon Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2002
Date Received
July 30, 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

Other clearances by Immunicon Corp.

  • K060110 — CELLTRACKS ANALYZER II (March 16, 2006)
  • K050145 — CELLTRACKA ANALYZER II (March 15, 2005)
  • K040077 — IMMUNICON CELLTRACKS AUTOPREP SYSTEM (March 12, 2004)
  • K030263 — IMMUNICON CELLTRACKS ANALYZER (November 24, 2003)
  • K030596 — IMMUNICON CELLSAVE PRESERVATIVE TUBE (August 8, 2003)

Other clearances for product code GKH

  • K100684 — CELLTRACKS AUTOPREP SYSTEM MODEL:9541 (August 26, 2010)
  • K040077 — IMMUNICON CELLTRACKS AUTOPREP SYSTEM (March 12, 2004)
  • K021150 — COULTER CELLPREP (June 11, 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)

FDA data resources