Search Results
Found 6 results
510(k) Data Aggregation
K Number
K121794Device Name
LIQUICHEK URINE CHEMISTRY CONTROL
Manufacturer
BIO-RAD, DIAGNOSTICS GRP.
Date Cleared
2012-07-11
(22 days)
Product Code
JJY
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
BIO-RAD, DIAGNOSTICS GRP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Liquichek Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Device Description
Liquichek Urine Chemistry Control is prepared from human urine with added constituents of human and animal origin, chemicals, preservatives and stabilizers. The control is provided in liquid form for convenience.
Ask a Question
K Number
K100727Device Name
LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK
Manufacturer
BIO-RAD, DIAGNOSTICS GRP.
Date Cleared
2010-09-14
(183 days)
Product Code
JJY
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
BIO-RAD, DIAGNOSTICS GRP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Liquid Assayed Multiqual is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
Device Description
Liquid Assayed Multiqual is prepared from human serum to which purified biochemical material (tissue extracts of human and animal origin), chemicals, drugs, preservatives, and stabilizers have been added.
Ask a Question
K Number
K072721Device Name
LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC
Manufacturer
BIO-RAD, DIAGNOSTICS GRP.
Date Cleared
2007-12-11
(76 days)
Product Code
DIF, REG
Regulation Number
862.3280Why did this record match?
Applicant Name (Manufacturer) :
BIO-RAD, DIAGNOSTICS GRP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Lyphochek Whole Blood Immunosuppressant Controls is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. The following analytes are listed in the package insert: Sirolimus, Tacrolimus, Cyclosporine. Abbott Immunosuppressant MCC is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. The following analytes are listed in the package insert: Sirolimus, Tacrolimus.
Device Description
Lyphochek Whole Blood Immunosuppressant Controls and Abbott Immunosuppressant MCC are both prepared from human whole blood, with added chemicals, and stabilizers.
Ask a Question
K Number
K072835Device Name
LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK
Manufacturer
BIO-RAD, DIAGNOSTICS GRP.
Date Cleared
2007-12-11
(69 days)
Product Code
JJY
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
BIO-RAD, DIAGNOSTICS GRP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Liquichek Microalbumin Control is intended for use as an assayed quality control urine to monitor the precision of laboratory procedures listed in the package insert.
Liquichek Microalbumin Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Device Description
Liquichek Microalbumin Control is prepared from human urine with added constituents of human, pure chemicals, preservatives and stabilizers. The contral is provided in Iliginal form for convenience.
Ask a Question
K Number
K071319Device Name
I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02
Manufacturer
BIO-RAD, DIAGNOSTICS GRP.
Date Cleared
2007-06-26
(47 days)
Product Code
GGN, REG
Regulation Number
864.5425Why did this record match?
Applicant Name (Manufacturer) :
BIO-RAD, DIAGNOSTICS GRP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
i-STAT® Activated Clotting Time (ACT) Control is used to verify the integrity of newly received i-STAT® Activated Clotting Time cartridges.
Device Description
This is a lyophilized product prepared from human plasma, with added purified I mo to a ly ophilizes. The control is provided in lyophilized form for increased stability.
Ask a Question
K Number
K070848Device Name
LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X
Manufacturer
BIO-RAD, DIAGNOSTICS GRP.
Date Cleared
2007-04-25
(28 days)
Product Code
JJW
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
BIO-RAD, DIAGNOSTICS GRP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Liquichek Urinalysis Control is intended for use as an assayed quality control urine to monitor the precision of urinalysis test procedures for the analytes listed in the package insert.
Device Description
Liquichek Urinalysis Control is prepared from human urine with added human erythrocytes, simulated leukocytes, constituents of animal origin, pure chemicals, preservatives and stabilizers. The control is provided in liquid form for convenience.
Ask a Question
Page 1 of 1