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De Novo DK800239

Device
Quality Control Kits For Blood Banking Reagents
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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Device Classification Under Section 513(f)(2)(de N
De Novo number
DK800239
510(k) number
DEVICECLASSIFICATIONUNDERSECTION513F2DENOVOQUICKLINKSSKIPTOMAINPAGECONTENTSKIPTOSEARCHSKIPTOTOPICSMENUSKIPTOCOMMONLIN
Product code
KSF  
Regulation
864.9650
Classification name
Kit, Quality Control For Blood Banking Reagents
Decision
Substantially Equivalent (SE)
Decision date
1980-02-21
Date received
1980-02-05
Classification advisory
Hematology
Review advisory
Hematology
Type
510(k) Traditional