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510(k) Data Aggregation
K Number
K971566Device Name
CREATINE KINASE-MB REAGENT SET
Manufacturer
Date Cleared
1997-07-14
(76 days)
Product Code
Regulation Number
862.1215Why did this record match?
Applicant Name (Manufacturer) :
HORIZON DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For in vitro diagnostic use in the quantitative determination of creatine kinase-MB in recommended when Acute Myocardial Infarction is suspected.
Device Description
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K Number
K933722Device Name
HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT
Manufacturer
Date Cleared
1996-06-13
(1046 days)
Product Code
Regulation Number
862.1705Why did this record match?
Applicant Name (Manufacturer) :
HORIZON DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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