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510(k) K040077

IMMUNICON CELLTRACKS AUTOPREP SYSTEM by Immunicon Corp. — Product Code GKH

K040077 is an FDA 510(k) premarket notification submitted by Immunicon Corp. for the device "IMMUNICON CELLTRACKS AUTOPREP SYSTEM". The FDA issued a decision of Substantially Equivalent on March 12, 2004. 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
March 12, 2004
Date Received
January 14, 2004
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)
  • K030263 — IMMUNICON CELLTRACKS ANALYZER (November 24, 2003)
  • K030596 — IMMUNICON CELLSAVE PRESERVATIVE TUBE (August 8, 2003)
  • K022512 — CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 (September 30, 2002)

Other clearances for product code GKH

  • K100684 — CELLTRACKS AUTOPREP SYSTEM MODEL:9541 (August 26, 2010)
  • K022512 — CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 (September 30, 2002)
  • 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