RIA-QUANT FPA TEST KIT— 510(k) K821151

Name: FDA 510(k) clearance K821151
Creator: U.S. Food and Drug Administration
Published: 1982-07-22

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K821151 for RIA-QUANT FPA TEST KIT, Substantially Equivalent on 1982-07-22. Applicant: Mallinckrodt Critical Care. Device class: 2.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Code DAN
Device class: Class 2
Regulation: 21 CFR 866.5350
Advisory panel: Immunology
Date received: 1982-04-26
Decision date: 1982-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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