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Found 4 results
510(k) Data Aggregation
K Number
K060510Device Name
DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT
Manufacturer
DREW SCIENTIFIC LTD.
Date Cleared
2006-06-19
(112 days)
Product Code
JJX
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
DREW SCIENTIFIC LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For in vitro diagnostic use only. The Drew Scientific Glycated Hemoglobin Five Level Linearity Kit is intended to verify the linearity of HbA1c assays across the patient reportable range (4 to 18%, NGSP aligned) using protocols established in individual laboratories.
Device Description
Not Found
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K Number
K043378Device Name
DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT
Manufacturer
DREW SCIENTIFIC LTD.
Date Cleared
2004-12-29
(21 days)
Product Code
JIT
Regulation Number
862.1150Why did this record match?
Applicant Name (Manufacturer) :
DREW SCIENTIFIC LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For in vitro diagnostic use only. These calibrators are intended for use with instruments for the measurement of HbA1c and are designed to allow calibration to either the American NGSP system or the International IFCC system.
Device Description
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K Number
K012152Device Name
DS30 HCY BLOOD COLLECTION TUBES
Manufacturer
DREW SCIENTIFIC LTD.
Date Cleared
2001-09-18
(69 days)
Product Code
GIM
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
DREW SCIENTIFIC LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Plastic, evacuated blood collection tube containing EDTA (anti-coagulant) and 3deazaadenosine (enzyme inhibitor) for the collection and stabilization of 2.5 mL whole blood prior to removal of plasma for total homocysteine measurement by HPLC for the detection of hyperhomocysteinæmia.
prescription use
Device Description
Plastic, evacuated blood collection tube containing EDTA (anti-coagulant) and 3deazaadenosine (enzyme inhibitor)
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K Number
K982003Device Name
DS30 HCY HOMOCYSTEINE ASSAY KIT
Manufacturer
DREW SCIENTIFIC LTD.
Date Cleared
1999-02-11
(248 days)
Product Code
LPS
Regulation Number
862.1377Why did this record match?
Applicant Name (Manufacturer) :
DREW SCIENTIFIC LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
In vitro quantitative measurement of total homocysteine (tHcy) concentration in plasma for detection of hyperhomocysteinemia.
Device Description
Not Found
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