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510(k) Data Aggregation
K Number
K070506Device Name
SMS MULTI GLUCOSE CONTROL, MODEL 2120049
Manufacturer
MEDICAL SPECIALTIES SUPPLY CO., INC.
Date Cleared
2007-04-18
(56 days)
Product Code
JJX
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL SPECIALTIES SUPPLY CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Roche Accu-chek Active, the Bayer Ascensia Contour, and the LifeScan OneTouch Ultra and FastTake Blood Glucose Monitors.
Device Description
The SMS Multi Glucose Control consists of a viscosity-adjusted, aqueous liquid control solution containing a known quantity of glucose. The product is packaged in plastic dropper tipped bottles for easy application of the control solutions to the test strips and a red coloration to aid the user to visually confirm application of the control. The product is nonhazardous and contains no human or animal derived materials.
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