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510(k) K842446

DILU-MATIC 140 by Abbott Diagnostics — Product Code GKH

K842446 is an FDA 510(k) premarket notification submitted by Abbott Diagnostics for the device "DILU-MATIC 140". The FDA issued a decision of Substantially Equivalent on September 6, 1984. The device falls under product code GKH (Apparatus, Automated Blood Cell Diluting), a Class I device regulated under 21 CFR 864.5240. Abbott Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1984
Date Received
June 21, 1984
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 Abbott Diagnostics

  • K964185 — IMX CA 125 (November 4, 1997)
  • K972182 — ABBOTT STREP A CONTROLS (August 13, 1997)
  • K961439 — ABBOTT CELL-DYN 4000 SYSTEM (October 18, 1996)
  • K890491 — CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER (April 18, 1989)
  • K881242 — CELL-DYN RAPID-LYSE AND HEMOGLOBLIN (April 21, 1988)
  • K881130 — CELL-DYN ISOTONIC DILUENT (March 31, 1988)
  • K873348 — CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. (September 9, 1987)
  • K873347 — CELL-DYN DIFF. SCREEN ISOTONIC DILUENT (September 9, 1987)
  • K873408 — MODEL 690 SPECTROPHOTOMETER (September 8, 1987)
  • K872761 — CELL-DYN 610 HEMATOLOGY ANALYZER (August 6, 1987)

Other clearances for product code GKH

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

FDA data resources