NEIA-FERRITIN ENZYMEIMMUNOASSAY— 510(k) K780490

Name: FDA 510(k) clearance K780490
Creator: U.S. Food and Drug Administration
Published: 1978-04-10

Substantially Equivalent

New England Immunology Assoc.

FDA 510(k) clearance K780490 for NEIA-FERRITIN ENZYMEIMMUNOASSAY, Substantially Equivalent on 1978-04-10. Applicant: New England Immunology Assoc.. Device class: 2.

Clearance details

Applicant: New England Immunology Assoc.
Product code: Code DBF
Device class: Class 2
Regulation: 21 CFR 866.5340
Advisory panel: Immunology
Date received: 1978-03-27
Decision date: 1978-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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