ADP REAGENT— 510(k) K910800

Clearance details

Applicant

Helena Laboratories

Product code

Code GHR

Device class

Class 2

Regulation

21 CFR 864.5700

Advisory panel

Hematology

Date received

1991-02-25

Decision date

1991-05-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Beaumont, TX, US

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