De Novo DK800189

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

<table Width="100%"> <tr> <td Width="15%" Nowrap> <table> <tr><td><a Href="/scripts/cdrh/devicesatfda/index.cfm"><img Src="../images/supersearch.gif" Border="0" Alt="Super Search Devices@FDA"></a></td></tr></table>

Contact

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

De Novo number

DK800189

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

1980-02-13

Date received

1980-01-29

Classification advisory

Hematology

Review advisory

Hematology

Type

510(k) Traditional