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510(k) K072640

IRISPEC,CA/CB/CC by Iris Diagnostics — Product Code JJW

K072640 is an FDA 510(k) premarket notification submitted by Iris Diagnostics for the device "IRISPEC,CA/CB/CC". The FDA issued a decision of Substantially Equivalent on December 21, 2007. The device falls under product code JJW (Urinalysis Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Iris Diagnostics has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2007
Date Received
September 18, 2007
Clearance Type
Abbreviated
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 Iris Diagnostics

  • K091539 — IQ 200 URINE ANALIZER BODY FLUIDS MODULE (August 31, 2010)

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)
  • 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)
  • K042446 — QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS (November 2, 2004)

FDA data resources