WAKO CPK TEST— 510(k) K832004

Clearance details

Applicant

Wako Chemicals USA, Inc.

Product code

Code JHY

Device class

Class 2

Regulation

21 CFR 862.1215

Advisory panel

Clinical Chemistry

Date received

1983-06-22

Decision date

1983-08-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

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