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

Name: FDA 510(k) clearance K191296
Creator: U.S. Food and Drug Administration
Published: 2020-08-11

Substantially Equivalent

Medtest DX

FDA 510(k) clearance K191296 for Pointe Scientific Creatinine Kinase (CK) Reagent Set, Substantially Equivalent on 2020-08-11. Applicant: Medtest DX. Device class: 2.

Clearance details

Applicant: Medtest DX
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
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

Download summary PDF View on FDA.gov ↗

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