De Novo DK792185

Device
Empty Containers For The Collection & Processing Of Blood/Blood Components
Requester
Device 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 Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Fo
Requester address
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Contact
Device Classification Under Section 513(f)(2)(de N
De Novo number
DK792185
510(k) number
DEVICECLASSIFICATIONUNDERSECTION513F2DENOVOQUICKLINKSSKIPTOMAINPAGECONTENTSKIPTOSEARCHSKIPTOTOPICSMENUSKIPTOCOMMONLIN
Product code
KSR  
Regulation
864.9100
Classification name
Container, Empty, For Collection & Processing Of Blood & Blood Components
Decision
Substantially Equivalent (SE)
Decision date
1979-12-28
Date received
1979-10-31
Classification advisory
Hematology
Review advisory
Hematology
Type
510(k) Traditional