CREATINE PHOSPHOKINASE (CPK) REAGENT SET— 510(k) K792533

Clearance details

Applicant

Macomb Chemical Co.

Product code

Code JHW

Device class

Class 2

Regulation

21 CFR 862.1215

Advisory panel

Clinical Chemistry

Date received

1979-12-07

Decision date

1980-01-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

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