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510(k) Data Aggregation
K Number
K061812Device Name
COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005
Manufacturer
ANALYTICON BIOTECHNOLOGIES AG
Date Cleared
2007-04-06
(284 days)
Product Code
JIL, CDM, CEN, JIN, JIO, JIR, JJB, JMA, JMT, KQO, LJX
Regulation Number
862.1340Why did this record match?
Applicant Name (Manufacturer) :
ANALYTICON BIOTECHNOLOGIES AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Combi Scan 500 is for use with Combi Screen test strips to determine the following parameters from urine: ascorbic acid, bilirubin, blood, glucose, ketones, leucocytes, nitrite, pH, protein, specific gravity, urobilinogen. These measurements are used in the evaluation of diabetes, liver diseases, haemolytic diseases, urogenital and kidney disorders or metabolic abnormalities. For professional use only, not for self testing!
Device Description
The Combi Scan 500 is a medium automated urine test strip analyser for use with Combi Screen test strips to determine one or more of the following parameters from urine: ascorbic acid, bilirubin, blood, glucose, ketones, leucocytes, nitrite, pH, protein, specific gravity. For professional use only!
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K Number
K061846Device Name
COMBI SCAN100
Manufacturer
ANALYTICON BIOTECHNOLOGIES AG
Date Cleared
2007-04-06
(284 days)
Product Code
JIL, CDM, CEN, JIN, JIO, JIR, JJB, JMA, JMT, JRE, KQO, LJX
Regulation Number
862.1340Why did this record match?
Applicant Name (Manufacturer) :
ANALYTICON BIOTECHNOLOGIES AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Combi Scan 100 is for use with Combi Screen test strips to determine the following parameters from urine: ascorbic acid, bilirubin, blood, glucose, ketones, leucocytes, nitrite, pH, protein, specific gravity, urobilinogen. These measurements are used in the evaluation of diabetes, liver diseases, haemolytic diseases, urogenital and kidney disorders or metabolic abnormalities. For professional use only, not for self testing!
Device Description
The Combi Scan 100 is a small urine test strip analyser for use with Combi Screen test strips to determine one or more of the following parameters from urine: ascorbic acid, bilirubin, blood, glucose, ketones, leucocytes, nitrite, pH, protein, specific gravity. For professional use only!
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K Number
K023885Device Name
COMBI-SCREEN, MODELS 10SL AND 11SL
Manufacturer
ANALYTICON BIOTECHNOLOGIES AG
Date Cleared
2003-10-21
(334 days)
Product Code
JIL, JIN, JJB, JMA, JMT
Regulation Number
862.1340Why did this record match?
Applicant Name (Manufacturer) :
ANALYTICON BIOTECHNOLOGIES AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Model 10SL: For rapid determination of Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Blood, Nitrite, pH-Value, Specific Gravity, and Leukocytes in urine
Model 11SL: For rapid determination of Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Blood, Nitrite, pH-Value, Specific Gravity, Leukocytes, and Ascorbic Acid in urine.
Device Description
The urine test strips can be used for the determination of the complete chemical urine status with the parameters: bilirubin, blood, ketones, glucose, leukocytes, nitrite, pH-value, protein, urobilinogen. In addition the specific gravity can be tested. With it early symptoms of three great groups of diseases can be indicated:
Disorders of the carbohydrate metabolism (diabetes)
Illness of the kidney and urinary passages (e.g. infections of urinary passages, tumors, glomerulonephritis, pyelonephritis)
Illness of liver and haemolytic disorders.
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