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510(k) K053253

HEMOCUE ALBUMIN 201 ANALYZING SYSTEM by Hemocue AB — Product Code KQO

K053253 is an FDA 510(k) premarket notification submitted by Hemocue AB for the device "HEMOCUE ALBUMIN 201 ANALYZING SYSTEM". The FDA issued a decision of Substantially Equivalent on February 17, 2006. The device falls under product code KQO (Automated Urinalysis System), a Class I device regulated under 21 CFR 862.2900. Hemocue AB has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2006
Date Received
November 21, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automated Urinalysis System
Device Class
Class I
Regulation Number
862.2900
Review Panel
CH
Submission Type

Other clearances by Hemocue AB

  • K201217 — HemoCue Hb 301 System (August 4, 2020)
  • K181751 — HemoCue Hb 801 System (February 1, 2019)
  • K071652 — HEMOCUE WBC SYSTEM (October 25, 2007)
  • 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)
  • 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 KQO

  • K141874 — URISCAN OPTIMA (May 28, 2015)
  • K142543 — Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid (May 11, 2015)
  • K140717 — CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALI (November 17, 2014)
  • K121456 — AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET (February 1, 2013)
  • K102188 — CYBOW READER, MODELS 300 & 720 (August 9, 2011)
  • K101852 — CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT (March 23, 2011)
  • K091472 — URITEST 50 AND URITEST 500 URINE ANALYZER (April 27, 2010)
  • K093555 — COBAS U411 TEST SYSTEM (April 2, 2010)
  • K093098 — AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM (December 23, 2009)
  • K070929 — ACON U120 URINE ANALYZER, MODEL U111-101 (July 30, 2007)

FDA data resources