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510(k) Data Aggregation
K Number
K062521Device Name
OXALATE URINE CONTROLS (NORMAL AND ELEVATED)
Manufacturer
Date Cleared
2007-03-16
(200 days)
Regulation Number
862.1150Why did this record match?
Applicant Name (Manufacturer) :
THERMO-ELECTRON CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Oxalate Normal and Elevated Controls are for use in the quality control of the Thermo Oxalate method for the quantitative determination of urine oxalate. The control is used for monitoring accuracy and precision on automated clinical chemistry analysers and for manual operations. It is for in vitro diagnostic use only.
The Oxalate Standard is intended for the calibration of Oxalate assays using the Thermo Oxalate Reagent. It is for in vitro diagnostic use only.
Device Description
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K Number
K052056Device Name
DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM
Manufacturer
Date Cleared
2005-09-23
(56 days)
Product Code
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
THERMO-ELECTRON CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Data-Trol A Abnormal Control serum is intended for monitoring the accuracy and precision of clinical chemistry test procedures. It is for in vitro diagnostic use only.
Data-Trol N Normal Control serum is intended for monitoring the accuracy and precision of clinical chemistry test procedures. It is for in vitro diagnostic use only.
Device Description
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