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510(k) K160062

AUTION ELEVEN Semi-Automated Urinalysis System by Arkray, Inc. — Product Code JIL

K160062 is an FDA 510(k) premarket notification submitted by Arkray, Inc. for the device "AUTION ELEVEN Semi-Automated Urinalysis System". The FDA issued a decision of Substantially Equivalent on October 7, 2016. The device falls under product code JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative)), a Class II device regulated under 21 CFR 862.1340. Arkray, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2016
Date Received
January 12, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Device Class
Class II
Regulation Number
862.1340
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)
  • K121456 — AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET (February 1, 2013)
  • 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 JIL

  • K193514 — AUTION MAX AX-4060 Urinalysis System (April 13, 2023)
  • K183432 — cobas u 601 urinalysis test system (May 7, 2019)
  • K173327 — DIP/U.S. Urine Analysis Test System (July 18, 2018)
  • K180356 — inui In-Home Urine Analysis Test System (May 25, 2018)
  • K181024 — DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips (May 23, 2018)
  • K171521 — DUS R-50S (Urine Chemistry system) (February 16, 2018)
  • K171083 — iChemVELOCITY Automated Urine Chemistry System (May 12, 2017)
  • K160372 — URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (July 22, 2016)
  • K141289 — TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS (July 24, 2015)
  • K131600 — URS-2GP (GLUCOSE PROTEIN) URINE STRIPS (May 29, 2014)

FDA data resources