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510(k) Data Aggregation
K Number
K990516Device Name
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
Manufacturer
EMD CHEMICALS INC.
Date Cleared
1999-03-31
(41 days)
Product Code
DNN
Regulation Number
862.3200Why did this record match?
Product Code :
DNN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ethyl Alcohol Clinical Standard Solutions are intended for use in the calibration and standardization of instruments and methods for the determination of Ethyl alcohol in whole blood or serum. The Standard Solutions may also be used for validation of the standardization of instruments and/or control materials.
Device Description
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K Number
K973054Device Name
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
Manufacturer
EMD CHEMICALS INC.
Date Cleared
1997-10-01
(47 days)
Product Code
DNN
Regulation Number
862.3200Why did this record match?
Product Code :
DNN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ethyl Alcohol Clinical Standard Solutions are intended for use in the calibration and standardization caruments and methods for the determination of ethyl alcohol in whole blood or serum. The Standard tions may also be used for validation of the laboratory's routine standards and/or control materials.
Device Description
Not Found
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