HYDRAGEL 6 CSF KIT— 510(k) K981048

Clearance details

Applicant

Morax

Product code

Code CFF

Device class

Class 2

Regulation

21 CFR 866.5510

Advisory panel

Immunology

Date received

1998-03-20

Decision date

1998-10-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Chelsea, MI, US

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