510(k) K191296— Pointe Scientific Creatinine Kinase (CK) Reagent Set

Substantially Equivalent

Medtest DX

Clearance details

Applicant: Medtest DX
Product code: Code CGS
Advisory panel: Clinical Chemistry
Date received: 2019-05-14
Decision date: 2020-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincoln Park, MI, US

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