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510(k) Data Aggregation
K Number
K021781Device Name
EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS
Manufacturer
Date Cleared
2002-08-30
(92 days)
Product Code
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
CHAY MEDICAL, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Excelsior 3ul blood glucose test strips are intended for both professional and home use when used with the Home Diagnostics, Inc. Prestige LX or Prestige IQ blood glucose meters. Excelsior 3ul test strips, when used with the aforementioned meters, will quantitatively measure glucose levels in fresh whole blood, which will provide the user essential information for the proper management of diabetes.
Device Description
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K Number
K013342Device Name
EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC.
Manufacturer
Date Cleared
2002-02-15
(129 days)
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
CHAY MEDICAL, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Excelsior blood glucose test strips are intended for both professional and home use when used with the Home Diagnostics, Inc. Prestige LX blood glucose meters. Excelsior test strips, when used with the Home Diagnostics, Inc. Prestige LX blood glucose meters, quantitatively measure glucose levels in fresh whole blood, which will provide the user essential information for the proper management of diabetes.
Device Description
Excelsior blood glucose test strips for use with the Home Diagnostics, Inc. Prestige LX Dood glucose system, and Prestige IQ blood glucose system.
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Ask a specific question about this device
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