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510(k) K971469

COULTER ACT TRON CELL CONTROL by Coulter Corp. — Product Code JPK

K971469 is an FDA 510(k) premarket notification submitted by Coulter Corp. for the device "COULTER ACT TRON CELL CONTROL". The FDA issued a decision of Substantially Equivalent on June 30, 1997. The device falls under product code JPK (Mixture, Hematology Quality Control), a Class II device regulated under 21 CFR 864.8625. Coulter Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1997
Date Received
April 22, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mixture, Hematology Quality Control
Device Class
Class II
Regulation Number
864.8625
Review Panel
HE
Submission Type

Other clearances by Coulter Corp.

  • K993356 — COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES (April 20, 2000)
  • K991070 — COULTER Z2 ANALYZER (May 11, 1999)
  • K990327 — RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS (April 26, 1999)
  • K990172 — TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME C (April 13, 1999)
  • K990352 — COULTER AC T DIFF 2 ANALYZER (April 1, 1999)
  • K984216 — IMMUNO-TROL CONTROL CELLS (March 16, 1999)
  • 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 JPK

  • K160586 — XN-L CHECK (December 22, 2016)
  • K160590 — XN CHECK (December 22, 2016)
  • K160588 — XN CHECK BF (December 22, 2016)
  • K160606 — BC-5D Hematology Control (September 1, 2016)
  • K141964 — XN CHECK (December 5, 2014)
  • K141957 — XN CHECK BF (December 5, 2014)
  • K130962 — R&D 5D RETIC HEMATOLOGY CONTROL (July 24, 2013)
  • K120742 — XN CHECK (October 19, 2012)
  • K120744 — XN CHECK BF (October 19, 2012)
  • K101578 — R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL (April 28, 2011)

FDA data resources