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510(k) K071652

HEMOCUE WBC SYSTEM by Hemocue AB — Product Code GKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2007
Date Received
June 18, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Cell, Automated (Particle Counter)
Device Class
Class II
Regulation Number
864.5200
Review Panel
HE
Submission Type

Other clearances by Hemocue AB

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  • K181751 — HemoCue Hb 801 System (February 1, 2019)
  • K060765 — HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES (September 6, 2006)
  • K061047 — HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 (June 8, 2006)
  • K053253 — HEMOCUE ALBUMIN 201 ANALYZING SYSTEM (February 17, 2006)
  • K041234 — HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM (June 10, 2004)
  • K041230 — CLINICAL LABORATORY ANALYZING SYSTEM (May 20, 2004)
  • K032203 — HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 (August 25, 2003)
  • K020935 — HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 (April 3, 2002)
  • K962415 — HEMOCUE B-GLCOSE SYSTEM (October 15, 1996)

Other clearances for product code GKL

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  • K091539 — IQ 200 URINE ANALIZER BODY FLUIDS MODULE (August 31, 2010)
  • K051693 — MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM (December 7, 2005)
  • K050235 — IQ 200 URINE ANALYZER BODY FLUIDS MODULE (March 23, 2005)
  • K032677 — SYSMEX POCH-100I (February 11, 2004)
  • K022331 — ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD (September 11, 2002)
  • K001683 — SYSMEX R-500 (August 21, 2000)
  • K991070 — COULTER Z2 ANALYZER (May 11, 1999)
  • K981950 — SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 (November 3, 1998)
  • K981761 — SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER (August 14, 1998)