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510(k) K823522

DILULAB 230 by Innovative Medical Systems, Inc. — Product Code GKH

K823522 is an FDA 510(k) premarket notification submitted by Innovative Medical Systems, Inc. for the device "DILULAB 230". The FDA issued a decision of Substantially Equivalent on December 28, 1982. The device falls under product code GKH (Apparatus, Automated Blood Cell Diluting), a Class I device regulated under 21 CFR 864.5240. Innovative Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1982
Date Received
November 29, 1982
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 Innovative Medical Systems, Inc.

  • K973035 — VIOLA II DENTAL CAMERA SYSTEM (September 24, 1997)
  • K951469 — BAZOOKA SYSTEM (June 28, 1995)
  • K933184 — POSITIVE AIRWAY PRESSURE SYSTEM (November 28, 1994)
  • K924590 — MICROWAVE AUTOMATED TISSUE PROCESSOR (December 29, 1992)
  • K922081 — LABOTECH AUTOMATED MICROTITER ANALYZER (September 2, 1992)
  • K921005 — AUTOLOADER (April 29, 1992)
  • K915457 — PHACO 20/20 SYSTEM I (February 24, 1992)
  • K915456 — PHACO 3000 LINEAR (February 12, 1992)
  • K883599 — LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) (September 2, 1988)
  • K880745 — LX-100 SLIDE STAINER (April 27, 1988)

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