FERRO-QUANT TM FE 59 TEST KIT— 510(k) K800868

Name: FDA 510(k) clearance K800868
Creator: U.S. Food and Drug Administration
Published: 1980-04-29

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K800868 for FERRO-QUANT TM FE 59 TEST KIT, Substantially Equivalent on 1980-04-29. Applicant: Mallinckrodt Critical Care. Device class: 1.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Code JQG
Device class: Class 1
Regulation: 21 CFR 862.1415
Advisory panel: Clinical Chemistry
Date received: 1980-04-17
Decision date: 1980-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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