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510(k) Data Aggregation
K Number
K051648Manufacturer
Date Cleared
2006-01-31
(224 days)
Regulation Number
862.1215Type
TraditionalPanel
Clinical ChemistryReference & Predicate Devices
N/A
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Device Name :
SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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