TRIGLYCERIDES TEST KIT— 510(k) K781477

Name: FDA 510(k) clearance K781477
Creator: U.S. Food and Drug Administration
Published: 1978-10-03

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K781477 for TRIGLYCERIDES TEST KIT, Substantially Equivalent on 1978-10-03. Applicant: Mallinckrodt Critical Care. Device class: 1.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1978-08-28
Decision date: 1978-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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