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510(k) K121456

AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL by Arkray, Inc. — Product Code KQO

K121456 is an FDA 510(k) premarket notification submitted by Arkray, Inc. for the device "AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL". The FDA issued a decision of Substantially Equivalent on February 1, 2013. The device falls under product code KQO (Automated Urinalysis System), a Class I device regulated under 21 CFR 862.2900. Arkray, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2013
Date Received
May 16, 2012
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 Arkray, Inc.

  • K232416 — AUTION EYE AI-4510 Urine Particle Analysis System (May 3, 2024)
  • K193514 — AUTION MAX AX-4060 Urinalysis System (April 13, 2023)
  • K221175 — Multi-Lancet Device 2, ReliOn Premier Lancing Device (October 17, 2022)
  • K200788 — Assure Titanium Blood Glucose Monitoring System (May 23, 2022)
  • K160062 — AUTION ELEVEN Semi-Automated Urinalysis System (October 7, 2016)
  • K093098 — AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM (December 23, 2009)
  • K053401 — SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS (March 24, 2006)
  • K051648 — SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS (January 31, 2006)
  • K051432 — SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS (June 17, 2005)
  • K050790 — SPOTCHEM II LDH TEST (June 6, 2005)

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)
  • 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)
  • K053253 — HEMOCUE ALBUMIN 201 ANALYZING SYSTEM (February 17, 2006)

FDA data resources