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510(k) K832713

IRI SPEC URINALYSIS CONTROL by Intl. Remote Imaging Systems — Product Code JJW

K832713 is an FDA 510(k) premarket notification submitted by Intl. Remote Imaging Systems for the device "IRI SPEC URINALYSIS CONTROL". The FDA issued a decision of Substantially Equivalent on December 22, 1983. The device falls under product code JJW (Urinalysis Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Intl. Remote Imaging Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1983
Date Received
August 12, 1983
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 Intl. Remote Imaging Systems

  • K022774 — IQ 200 SYSTEM (October 21, 2002)
  • K000373 — 939UDX URINE PATHOLOGY SYSTEM (April 14, 2000)
  • K972141 — THE YELLOW IRIS URINALYSIS WORKSTATION (August 25, 1997)
  • K953116 — WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER (May 13, 1996)
  • K960054 — 900UDX URINE PATHOLOGY SYSTEM (March 22, 1996)
  • K954006 — YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY (March 12, 1996)
  • K943463 — THE YELLOW IRIS (September 20, 1994)
  • K934539 — THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABIL (March 30, 1994)
  • K914256 — YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU (May 1, 1992)
  • K893530 — IRISTAIN FORMULA 2, PARTS 1 AND 2 (June 13, 1989)

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