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510(k) Data Aggregation
K Number
K972495Device Name
ACCUMETER THEOPHYLLINE TEST
Manufacturer
CHEMTRAK, INC.
Date Cleared
1997-10-10
(99 days)
Product Code
KLS
Regulation Number
862.3880Why did this record match?
Applicant Name (Manufacturer) :
CHEMTRAK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ChemTrak AccuMeter® Theophylline Test provides a rapid, noninstrumented enzyme immunochromatographic method for in vitro quantitative measurement of Theophylline concentrations in ambulatory patients using fingerstick whole blood, heparinized venous whole blood or serum. This test has not been validated for use with blood from neonates.
Device Description
The AccuMeter Theophylline Test is a rapid immunoassay for the quantitative detection of theophylline, using HRP labeled anti-theophylline antibodies and immobilized monoclonal anti-theophylline antibodies. The immunospecific signal is measured by the height of the enzyme label along the test strip.
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K Number
K965099Device Name
ACCUMETER H. PYLORI TEST
Manufacturer
CHEMTRAK, INC.
Date Cleared
1997-02-20
(62 days)
Product Code
LYR
Regulation Number
866.3110Why did this record match?
Applicant Name (Manufacturer) :
CHEMTRAK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K960478Device Name
ACCUMETER H. PYLORI TEST
Manufacturer
CHEMTRAK, INC.
Date Cleared
1996-06-27
(146 days)
Product Code
LYR
Regulation Number
866.3110Why did this record match?
Applicant Name (Manufacturer) :
CHEMTRAK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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