De Novo DK760123

Device

Stabilized Enzyme Solutions

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

DK760123

510(k) number

DEVICECLASSIFICATIONUNDERSECTION513F2DENOVOQUICKLINKSSKIPTOMAINPAGECONTENTSKIPTOSEARCHSKIPTOTOPICSMENUSKIPTOCOMMONLIN

Product code

KSK  

Regulation

864.9400

Classification name

Solution, Stabilized Enzyme

Decision

Substantially Equivalent (SE)

Decision date

1976-07-20

Date received

1976-06-28

Classification advisory

Hematology

Review advisory

Hematology

Type

510(k) Traditional