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Found 4 results
510(k) Data Aggregation
K Number
K964278Device Name
WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6
Manufacturer
Date Cleared
1996-11-22
(25 days)
Product Code
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
CLINICAL CONTROLS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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K Number
K962432Device Name
LIQUISPEX URINE (MICRO)ALBUMIN CONTROL
Manufacturer
Date Cleared
1996-07-05
(11 days)
Product Code
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
CLINICAL CONTROLS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K955690Device Name
AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3
Manufacturer
Date Cleared
1996-04-24
(132 days)
Product Code
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
CLINICAL CONTROLS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K955691Device Name
SERUM VOLATILES CONTROL LEVEL 1 & 2
Manufacturer
Date Cleared
1996-04-24
(132 days)
Product Code
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
CLINICAL CONTROLS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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