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510(k) K945913

IRISPEC URINE CHEMISTRY CONTROL PART A AND B by International Remote Imaging Systems — Product Code JJW

K945913 is an FDA 510(k) premarket notification submitted by International Remote Imaging Systems for the device "IRISPEC URINE CHEMISTRY CONTROL PART A AND B". The FDA issued a decision of Substantially Equivalent on April 5, 1995. The device falls under product code JJW (Urinalysis Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. International Remote Imaging Systems has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1995
Date Received
December 2, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urinalysis Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by International Remote Imaging Systems

  • K030600 — AUTION JET AJ-4270 URINE ANALYZER (July 11, 2003)
  • K013783 — AUTION MAX AX-4280 URINALYSIS SYSTEM (January 18, 2002)

Other clearances for product code JJW

  • K170091 — UA-Cellular Complete (February 9, 2017)
  • K142262 — AUTION CHECK PLUS (April 10, 2015)
  • K131444 — UA-CELLULAR COMPLETE (January 29, 2014)
  • K110846 — RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 (September 30, 2011)
  • K103387 — MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY (February 2, 2011)
  • K081908 — CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 (January 16, 2009)
  • K072640 — IRISPEC,CA/CB/CC (December 21, 2007)
  • K070848 — LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,43 (April 25, 2007)
  • K052242 — ADVIA CHEMISTRY MICROALBUMIN CONTROLS (October 3, 2005)
  • K043266 — RANDOX URINE CONTROLS (February 15, 2005)

FDA data resources