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510(k) Data Aggregation
K Number
K081938Device Name
ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30
Manufacturer
GENZYME DIAGNOSTICS P.E.I. INC.
Date Cleared
2009-05-01
(297 days)
Product Code
LDP
Regulation Number
862.3030Why did this record match?
Applicant Name (Manufacturer) :
GENZYME DIAGNOSTICS P.E.I. INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity.
Device Description
For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity. Excessive amounts of acetaminophen leads to hepatotoxicity and nephrotoxicity. In acute overdosage, acetaminophen can cause severe hepatic damage leading to hepatic failure if untreated. Reagent is a two-part liquid in plastic bottles packaged in the appropriate box.
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K Number
K082210Device Name
TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30
Manufacturer
GENZYME DIAGNOSTICS P.E.I. INC.
Date Cleared
2008-12-16
(132 days)
Product Code
CIG
Regulation Number
862.1110Why did this record match?
Applicant Name (Manufacturer) :
GENZYME DIAGNOSTICS P.E.I. INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the IN VITRO quantitative measurement of Total Bilirubin in serum and plasma.
Measurement of Total Bilirubin is used in the diagnosis and management of liver disease, biliary tract obstruction, various hemolytic diseases and disorders involving the metabolism of bilirubin.
Device Description
Not Found
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