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510(k) Data Aggregation
K Number
K042767Device Name
DATAPRO CLINICAL CHELISTRY ANALYZER
Manufacturer
THERMO ELECTRON CORPORATION
Date Cleared
2005-04-27
(204 days)
Product Code
CFR, CDO, CDQ, CDT, CEK, CEO, CGX, CHH, CIC, CIG, CIT, CIX, CJE, CKA, JJE
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
THERMO ELECTRON CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DataPro™/DataPro Plus™ Clinical Chemistry Analyzer is a fully automated clinical chemistry analyzer intended for routine diagnostic clinical laboratory use. The DataPro™ has replaceable parts, automated maintenance monitoring and backup of both patient and system data. With a throughput of up to 230 tests per hour, the DataPro™ is intended for small and medium-sized laboratories, or as a backup analyzer in large volume laboratories.
The DataPro™/DataPro Plus™ Clinical Chemistry Analyzer is intended to be used in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae related to the measurement of various clinical assays, such as Albumin, Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Urea Nitrogen (BJ N), Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, Phosphorus, Total Billirubin, Total Protein, Triglyceride, and Uric Acid.
The DataPro™, and all of the reagents included in this test system are for in vitro diagnostic use only.
Device Description
The DataPro™/DataPro Plus™ Clinical Chemistry Analyzer is a fully automated clinical chemistry analyzer intended for routine diagnostic clinical laboratory use. The DataPro™ has replaceable parts, automated maintenance monitoring and backup of both patient and system data. With a throughput of up to 230 tests per hour, the DataPro™ is intended for small and medium-sized laboratories, or as a backup analyzer in large volume laboratories.
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K Number
K041657Device Name
THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT
Manufacturer
THERMO ELECTRON CORPORATION
Date Cleared
2004-08-30
(73 days)
Product Code
KQN, JIS, JJX
Regulation Number
862.1090Why did this record match?
Applicant Name (Manufacturer) :
THERMO ELECTRON CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. The Thermo Electron Infinity™ ACE Reagent Kit is intended for the quantitative determination of ACE in human serum or plasma. The product is for in vitro diagnostic use only. Measurements obtained by this device are used in the diagnosis and treatment of diseases such as sarcoidosis, a disease characterized by the formation of nodules in the lungs, bones, and skin, and Gaucher`s disease, a hereditary disorder affecting the spleen.
2. The Thermo Electron Infinity™ ACE Calibrator is intended for the calibration of ACE assays. The product is for in vitro diagnostic use only.
3. The Thermo Electron ACE Normal and Elevated Controls are intended for monitoring the accuracy and precision of ACE assays. The product is for in vitro diagnostic use only.
Device Description
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