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Found 3 results
510(k) Data Aggregation
K Number
K982539Device Name
HDLC PRECIPITATING REAGENT
Manufacturer
AC BIOCHEMICALS, INC.
Date Cleared
1998-09-15
(56 days)
Product Code
LBS
Regulation Number
862.1475Why did this record match?
Applicant Name (Manufacturer) :
AC BIOCHEMICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HDLC Precipitating Reagent is to be used in the separation of HDL from other serum lipoproteins to provide valuable information for the prediction of coronary heart disease when used in conjunction with total cholesterol and triglyceride determinations.
Device Description
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K Number
K980012Device Name
CREATINE KINASE REAGENT
Manufacturer
AC BIOCHEMICALS, INC.
Date Cleared
1998-02-25
(54 days)
Product Code
JHX
Regulation Number
862.1215Why did this record match?
Applicant Name (Manufacturer) :
AC BIOCHEMICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Creatine kinase Reagent is to be used in the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscle dystrophy.
Device Description
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K Number
K980013Device Name
AMYLASE
Manufacturer
AC BIOCHEMICALS, INC.
Date Cleared
1998-02-04
(33 days)
Product Code
CIJ
Regulation Number
862.1070Why did this record match?
Applicant Name (Manufacturer) :
AC BIOCHEMICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Amylase Reagent is to be used in the assessment of pancreatitis.
Device Description
Not Found
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