HYDRAGEL 15 HB A1C KIT— 510(k) K963844

Clearance details

Applicant

Morax

Product code

Code LCP

Device class

Class 2

Regulation

21 CFR 864.7470

Advisory panel

Hematology

Date received

1996-09-25

Decision date

1997-04-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Chelsea, MI, US

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