ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M

Flow Cytometric Test System For Hematopoietic Neoplasms

Beckman Coulter

The following data is part of a De Novo classification by Beckman Coulter with the FDA for Clearllab T1, Clearllab T2, Clearllab B1, Clearllab B2, Clearllab M.

Pre-market Notification Details

DeNovo IDDEN160047
Device Name:ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M
ClassificationFlow Cytometric Test System For Hematopoietic Neoplasms
Applicant Beckman Coulter 11800 Sw 147th Ave Miami,  FL  33196
ContactAnthony Dennis
Product CodePWD  
CFR Regulation Number864.7010 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardImmunology
Classification AdvisoryHematology
TypeDirect
Date Received2016-10-03
Decision Date2017-06-29
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590671013 DEN160047 000
15099590671006 DEN160047 000
15099590670993 DEN160047 000
15099590670986 DEN160047 000
15099590670979 DEN160047 000

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