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510(k) K061559

ACON URINALYSIS REAGENT STRIPS by Acon Laboratories Co. — Product Code CDM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2006
Date Received
June 5, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
Device Class
Class I
Regulation Number
862.1785
Review Panel
CH
Submission Type

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Other clearances for product code CDM

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  • K821799 — FITKIT I CHECKUP KIT (August 16, 1983)
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  • K831623 — DIA STRIPS SYSTEM (July 28, 1983)
  • K790965 — REAGENT STRIPS FOR URINALYSIS (June 28, 1979)