Search Results
Found 4 results
510(k) Data Aggregation
K Number
K033344Device Name
LIGAND PLUS CONTROL LEVEL 1-3
Manufacturer
CONSOLIDATED TECHNOLOGY
Date Cleared
2004-01-16
(88 days)
Product Code
JJY, DIF
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
CONSOLIDATED TECHNOLOGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LIGAND PLUS CONTROL, Levels 1, 2 and 3, is a lyophilized human serum based assayed quality control material intended to monitor the performance of clinical immunoassay test procedures that analyze immunochemistries and therapeutic drugs as listed in this package insert.
Device Description
LIGAND PLUS CONTROL is designed to monitor the performance of test procedures that analyze immunochemistries and therapeutic drugs as listed in the package insert. Human origin components are added to a human serum based matrix. The product contains <0.1% sodium azide. This product will be offered as an assayed or unassayed three level control.
Ask a Question
K Number
K023731Device Name
QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), LEVELS 1, 2, AND 3
Manufacturer
CONSOLIDATED TECHNOLOGY
Date Cleared
2002-12-24
(48 days)
Product Code
JJY
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
CONSOLIDATED TECHNOLOGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
QUICKCHECK LIQUID CHEMISTRY CONTROL, Levels 1, 2 and 3, is a liquid human serum based assayed quality control material intended to monitor the performance of clinical test procedures that analyze routine chemistry analytes as listed in this package insert.
Device Description
QUICKCHECK LIQUID CHEMISTRY CONTROL is designed to monitor the performance of test procedures that analyze a number of routine chemistry analytes as listed in the package insert. This product will be offered as an assayed and unassayed control. In addition, the control is being expanded to three levels.
Ask a Question
K Number
K020237Device Name
IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3
Manufacturer
CONSOLIDATED TECHNOLOGY
Date Cleared
2002-03-19
(55 days)
Product Code
JJY
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
CONSOLIDATED TECHNOLOGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3, is a lyophilized human serum based assayed quality control material intended to monitor the performance of clinical immunoassay test procedures that analyze immunochemistries and theraputic drugs as listed in this package insert.
Device Description
IMMUNOASSAY PLUS CONTROL is designed to monitor the performance of test procedures that analyze immunochemistries and therapeutic drugs as listed in the package insert. Human origin components are added to a human serum based matrix. The product contains 0.1% sodium azide. IMMUNOASSAY PLUS CONTROL will be offered in three levels of 5.0 mL filled vials.
Ask a Question
K Number
K003716Device Name
CONFORMANCE CHEMISTRY CONTROL C3
Manufacturer
CONSOLIDATED TECHNOLOGY
Date Cleared
2000-12-20
(19 days)
Product Code
JJY
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
CONSOLIDATED TECHNOLOGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1