De Novo DK780556

Device

Potentiating Media For In Vitro Diagnostic Use

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

DK780556

510(k) number

DEVICECLASSIFICATIONUNDERSECTION513F2DENOVOQUICKLINKSSKIPTOMAINPAGECONTENTSKIPTOSEARCHSKIPTOTOPICSMENUSKIPTOCOMMONLIN

Product code

KSG  

Regulation

864.9600

Classification name

Media, Potentiating For In Vitro Diagnostic Use

Decision

Substantially Equivalent (SE)

Decision date

1978-04-24

Date received

1978-04-05

Classification advisory

Hematology

Review advisory

Hematology

Type

510(k) Traditional