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510(k) Data Aggregation
K Number
K964916Device Name
GAMMA-GLUTAMYL TRANSPEPTIDASEManufacturer
Date Cleared
1997-01-10
(32 days)
Product Code
Regulation Number
862.1360Type
TraditionalPanel
Clinical ChemistryReference & Predicate Devices
N/A
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Device Name :
GAMMA-GLUTAMYL TRANSPEPTIDASE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
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