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510(k) K761137

MICROSAMPLE BLOOD COLLECTION DEVICE by Ortho Diagnostics, Inc. — Product Code GKH

K761137 is an FDA 510(k) premarket notification submitted by Ortho Diagnostics, Inc. for the device "MICROSAMPLE BLOOD COLLECTION DEVICE". The FDA issued a decision of Substantially Equivalent on February 7, 1977. The device falls under product code GKH (Apparatus, Automated Blood Cell Diluting), a Class I device regulated under 21 CFR 864.5240. Ortho Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1977
Date Received
November 24, 1976
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 Ortho Diagnostics, Inc.

  • K802404 — ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE (October 23, 1980)
  • K801507 — ANTIGEN CONTROL CELLS (August 20, 1980)
  • K800357 — BI-LEVEL ASSAYED CARD. DRUG CONT., I,II (April 16, 1980)
  • K800310 — ORTHO ANTISERA CONTROL (March 5, 1980)
  • K791791 — ORTHO ANTIBODY ENHANCEMENT SOLUTION (October 11, 1979)
  • K791301 — ORTHO TSH RIA KIT (September 24, 1979)
  • K790813 — MULTECON BLOOD GAS CONTROL (June 28, 1979)
  • K782063 — PREGNANCY, SENSIDEX TUBE TEST (April 4, 1979)
  • K782166 — SLIDE TEST FOR PREGNANCY, GRAVINDEX 90 (April 4, 1979)
  • K781638 — RUBINDEX*DIRECT SYSTEM (December 20, 1978)

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