De Novo DK802120

Device

Identification System For Hepatitis B Antigen

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

DK802120

510(k) number

DEVICECLASSIFICATIONUNDERSECTION513F2DENOVOQUICKLINKSSKIPTOMAINPAGECONTENTSKIPTOSEARCHSKIPTOTOPICSMENUSKIPTOCOMMONLIN

Product code

KSJ  

Regulation

Device Classification Under Section 513(f)(2)(de N

Classification name

System, Identification, Hepatitis B Antigen

Decision

Substantially Equivalent (SE)

Decision date

1980-10-20

Date received

1980-09-04

Classification advisory

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 &amp; Drug Administration &nbsp; Follow FDA En Espa&ntilde;ol Search FDA &nbsp; Home Fo

Review advisory

Hematology

Type

510(k) Traditional