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510(k) K103387

MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL by ACON Laboratories, Inc. — Product Code JJW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2011
Date Received
November 18, 2010
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

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Other clearances for product code JJW

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  • 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)