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510(k) Data Aggregation
K Number
K003030Device Name
LYPHOCHEK HEMOGLOBIN ALC LINEARITY SETManufacturer
Date Cleared
2000-11-29
(62 days)
Product Code
Regulation Number
864.8625Type
TraditionalPanel
HematologyReference & Predicate Devices
N/A
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Device Name :
LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
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