AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT— 510(k) K780783

Name: FDA 510(k) clearance K780783
Creator: U.S. Food and Drug Administration
Published: 1978-06-06

Substantially Equivalent

J.T. Baker Chemical Co.

FDA 510(k) clearance K780783 for AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT, Substantially Equivalent on 1978-06-06. Applicant: J.T. Baker Chemical Co.. Device class: 1.

Clearance details

Applicant: J.T. Baker Chemical Co.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1978-05-12
Decision date: 1978-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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