NEIA TRANSFERRIN ENZYMEIMMUNOASSAY— 510(k) K813288

Name: FDA 510(k) clearance K813288
Creator: U.S. Food and Drug Administration
Published: 1981-12-17

Substantially Equivalent

New England Immunology Assoc.

FDA 510(k) clearance K813288 for NEIA TRANSFERRIN ENZYMEIMMUNOASSAY, Substantially Equivalent on 1981-12-17. Applicant: New England Immunology Assoc.. Device class: 2.

Clearance details

Applicant: New England Immunology Assoc.
Product code: Code DDG
Device class: Class 2
Regulation: 21 CFR 866.5880
Advisory panel: Immunology
Date received: 1981-11-23
Decision date: 1981-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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