REAGENT FOR DETERM. CREATINE PHOSPHOKINA— 510(k) K800684

Clearance details

Applicant

Diagnostic Solutions, Inc.

Product code

Code JHY

Device class

Class 2

Regulation

21 CFR 862.1215

Advisory panel

Clinical Chemistry

Date received

1980-03-26

Decision date

1980-05-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

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