Home / 510(k) Clearances / K030600

510(k) K030600

AUTION JET AJ-4270 URINE ANALYZER by International Remote Imaging Systems — Product Code KQO

K030600 is an FDA 510(k) premarket notification submitted by International Remote Imaging Systems for the device "AUTION JET AJ-4270 URINE ANALYZER". The FDA issued a decision of Substantially Equivalent on July 11, 2003. The device falls under product code KQO (Automated Urinalysis System), a Class I device regulated under 21 CFR 862.2900. International Remote Imaging Systems has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2003
Date Received
February 25, 2003
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 International Remote Imaging Systems

  • K013783 — AUTION MAX AX-4280 URINALYSIS SYSTEM (January 18, 2002)
  • K945913 — IRISPEC URINE CHEMISTRY CONTROL PART A AND B (April 5, 1995)

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