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510(k) Data Aggregation
K Number
K041635Device Name
G5 I HBA1C TEST, G5 II HBA1C TEST
Manufacturer
PROVALIS DIAGNOSTICS LTD.
Date Cleared
2004-08-16
(61 days)
Product Code
LCP, GGM
Regulation Number
864.7470Why did this record match?
Applicant Name (Manufacturer) :
PROVALIS DIAGNOSTICS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The G5 I HbA₁c assay is an affinity chromatography method and is intended for the in-vitro quantitative determination of HbA₁c in capillary blood taken from a finger prick or whole blood in EDTA. The test is indicated for use by diabetics for monitoring the time averaged blood glucose levels of known diabetics as an indicator of overall glycaemic control. The G5 I HbA₁c assay is intended for use in a physicians/doctors office. The assay is not intended for use as a home use or for self-testing.
The G5 II HbA1c assay is an affinity chromatography method and is intended for the in-vitro quantitative determination of HbA1c in capillary blood taken from a finger prick. The test is indicated for use by diabetics for monitoring the time averaged blood glucose levels of known diabetics as an indicator of overall glycaemic control. The G5 II HbA1c assay is intended for use as a prescription home use test.
Device Description
Instrument read, single use in vitro test for the quantitative determination of glycated haemoglobin (GHb) in diabetics.
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K Number
K011933Device Name
GLYCOSAL II HBA 1C TEST
Manufacturer
PROVALIS DIAGNOSTICS LTD.
Date Cleared
2001-11-02
(135 days)
Product Code
LCP
Regulation Number
864.7470Why did this record match?
Applicant Name (Manufacturer) :
PROVALIS DIAGNOSTICS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Glycosal™ II HbA1c test is an affinity chromatography method and is intended for the in-vitro quantitative determination of HbA1c in capillary blood taken from a finger prick. The test is indicated for use by diabetics for monitoring the time averaged blood glucose levels of known diabetics as an indicator of overall glycaemic control. The Glycosal™ II HbA1c test is intended for use as a prescription home use test.
Device Description
Instrument read, single use in vitro test for the quantitative determination of glycated hemoglobin (GHb) in diabetics.
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K Number
K001392Device Name
GLYCOSAL HBA1C TEST
Manufacturer
PROVALIS DIAGNOSTICS LTD.
Date Cleared
2000-08-21
(110 days)
Product Code
LCP
Regulation Number
864.7470Why did this record match?
Applicant Name (Manufacturer) :
PROVALIS DIAGNOSTICS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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