BETA THALQUIK COLUMN #5341— 510(k) K823870

Clearance details

Applicant

Helena Laboratories

Product code

Code JPD

Device class

Class 2

Regulation

21 CFR 864.7400

Advisory panel

Hematology

Date received

1982-12-23

Decision date

1983-02-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

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