SPAC T4 RIA TEST KIT— 510(k) K820725

Name: FDA 510(k) clearance K820725
Creator: U.S. Food and Drug Administration
Published: 1982-06-01

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K820725 for SPAC T4 RIA TEST KIT, Substantially Equivalent on 1982-06-01. Applicant: Mallinckrodt Critical Care. Device class: 2.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Product code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1982-03-17
Decision date: 1982-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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