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510(k) K023928

MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL by Medical Analysis Systems, Inc. — Product Code JJW

K023928 is an FDA 510(k) premarket notification submitted by Medical Analysis Systems, Inc. for the device "MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL". The FDA issued a decision of Substantially Equivalent on December 11, 2002. The device falls under product code JJW (Urinalysis Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Medical Analysis Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2002
Date Received
November 25, 2002
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 Medical Analysis Systems, Inc.

  • K042717 — MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL (November 5, 2004)
  • K041194 — ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, (August 16, 2004)
  • K040880 — MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 (April 28, 2004)
  • K032826 — MAS PAR TDM (October 9, 2003)
  • K032335 — MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL (August 19, 2003)
  • K031890 — MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL (July 16, 2003)
  • K031392 — MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL (July 1, 2003)
  • K031441 — URICHEMTRAK LIQUID ASSAYED URINE CONTROL (July 1, 2003)
  • K031364 — MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3 (May 30, 2003)
  • K030942 — MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL (April 28, 2003)

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