CREATINE KINASE LIQUID REAGENT, MODEL C519-440— 510(k) K072548

Name: FDA 510(k) clearance K072548
Creator: U.S. Food and Drug Administration
Published: 2008-04-18

Substantially Equivalent

Teco Diagnostics

FDA 510(k) clearance K072548 for CREATINE KINASE LIQUID REAGENT, MODEL C519-440, Substantially Equivalent on 2008-04-18. Applicant: Teco Diagnostics. Device class: 2.

Clearance details

Applicant: Teco Diagnostics
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 2007-09-10
Decision date: 2008-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

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