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Found 3 results
510(k) Data Aggregation
K Number
K163629Device Name
Audit MicroControls Linearity FD Tumor Markers II
Manufacturer
Aalto Scientific, Ltd.
Date Cleared
2017-03-10
(78 days)
Product Code
JJY, JJX
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
Aalto Scientific, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Audit® MicroControls™ Linearity FD Tumor Markers II is intended to simulate human patient samples for use as assayed quality control material, determining linearity, callbration verification of reportable range for the HE4 and HER2 analytes.
The Audit® MicroControlsTM Linearity FD Tumor Markers II is for In Vitro Diagnostic use only.
Device Description
The Audit® MicroControls™ Linearity FD Tumor Markers II is an in-vitro diagnostic device consisting of sets of 5 levels of freeze-dried, linearity material and additives in human based serum. The product contains the following analytes: HE4 and HER2. Each set consists of 5 levels labeled Level A, B, C, D and E. Each level has a fill size of 1ml. Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.
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K Number
K161874Device Name
Audit MicroControls Linearity DROP LQ Blood Glucose
Manufacturer
AALTO SCIENTIFIC, LTD.
Date Cleared
2016-08-10
(33 days)
Product Code
JJX
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
AALTO SCIENTIFIC, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is intended to simulate human patient samples for use as assayed quality control material, determining linearity, calibration, and the verification of reportable range for the glucose analyte.
The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is for In Vitro Diagnostic use only.
Device Description
The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is an in-vitro diagnostic device consisting of sets of 5 levels of liquid, linearity material and additives in human based serum. The product contains the following analyte: glucose. Each set consists of 5 levels labeled Level A, B, C, D and E. Each level has a fill size of 1ml. Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.
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K Number
K143571Device Name
Audit MicroControls Linearity LQ Cystatin-C
Manufacturer
AALTO SCIENTIFIC, LTD.
Date Cleared
2015-01-23
(37 days)
Product Code
JJX
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
AALTO SCIENTIFIC, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Linearity LQ Cystatin-C is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration, and the verification of reportable range for the Cystatin-C analyte.
The Linearity LQ Cystatin-C is for In Vitro Diagnostic use only.
Device Description
The Audit® MicroControls™ Linearity LQ Cystatin-C product is an in-vitro diagnostic device consisting of one set of five levels of liquid, linearity/QC material. For the set there are five levels labeled A, B, C, D and E. The set contains 1ml for each level. The set contains the Cystatin-C analyte and additives in human and bovine based serum. Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.
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