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510(k) Data Aggregation
K Number
K003054Device Name
AUTOSTAT II ENA-6 PROFILE ELISAManufacturer
Date Cleared
2000-10-13
(11 days)
Product Code
Regulation Number
866.5100Type
TraditionalPanel
ImmunologyReference & Predicate Devices
N/A
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Device Name :
AUTOSTAT II ENA-6 PROFILE ELISA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
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