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510(k) K935953

COULTER MULTI Q PREP by Coulter Corp. — Product Code GKH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1994
Date Received
December 13, 1993
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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  • K982167 — CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH (November 9, 1998)
  • K982166 — CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH (November 5, 1998)
  • K982172 — CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER C (September 24, 1998)
  • K973634 — COULTER AC.T DIFF ANALYZER (October 29, 1997)

Other clearances for product code GKH

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  • K040077 — IMMUNICON CELLTRACKS AUTOPREP SYSTEM (March 12, 2004)
  • K022512 — CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 (September 30, 2002)
  • K021150 — COULTER CELLPREP (June 11, 2002)
  • 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)