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510(k) Data Aggregation
K Number
K961991Device Name
ACL 6000 SYSTEM (ACL 6000)Manufacturer
Date Cleared
1996-09-04
(106 days)
Product Code
Regulation Number
864.5400Type
TraditionalPanel
HematologyReference & Predicate Devices
N/A
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Device Name :
ACL 6000 SYSTEM (ACL 6000)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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