Home / 510(k) Clearances / K110846

510(k) K110846

RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 by Randox Laboratories Limited — Product Code JJW

K110846 is an FDA 510(k) premarket notification submitted by Randox Laboratories Limited for the device "RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2". The FDA issued a decision of Substantially Equivalent on September 30, 2011. The device falls under product code JJW (Urinalysis Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Randox Laboratories Limited has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2011
Date Received
March 28, 2011
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 Randox Laboratories Limited

  • K250741 — Evidence MultiSTAT DOA Urine MultiPlex (January 23, 2026)
  • K220451 — Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT (October 5, 2023)
  • K221550 — Evidence MultiSTAT DOA Urine MultiPlex (October 5, 2023)
  • K162275 — Randox RX Daytona Plus Alkaline Phosphatase (ALP) (April 21, 2017)
  • K161691 — Direct LDL Cholesterol (LDL) (March 20, 2017)
  • K152343 — Direct Bilirubin (February 16, 2016)
  • K152344 — Total Bilirubin (January 28, 2016)
  • K150819 — Triglycerides (August 6, 2015)
  • K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (December 8, 2014)
  • K142181 — RANDOX ALDOLASE CALIBRATION SERUM (September 18, 2014)

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

FDA data resources