Neia-Ferritin Enzymeimmunassay Kit

FDA 510(k) K790490 · New England Immunology Assoc.

Substantially Equivalent

510(k) numberK790490

Submission

Device name
Neia-Ferritin Enzymeimmunassay Kit
Applicant
New England Immunology Assoc.
Mchenry, IL, US
Received
March 8, 1979
Decision date
April 23, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DBF – Ferritin, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5340
Specialty
Immunology

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More from Reference Diagnostics, Inc.

510(k)DeviceDecision
K813288Neia Transferrin EnzymeimmunoassayDDG · Traditional 12/17/1981SE
K811757Neia Pap EnzymeimmunoassayJFH · Traditional 08/13/1981SE
K780490Neia-Ferritin EnzymeimmunoassayDBF · Traditional 04/10/1978SE

Questions and answers

When was Neia-Ferritin Enzymeimmunassay Kit cleared by the FDA?

Neia-Ferritin Enzymeimmunassay Kit (K790490) received a 510(k) decision of Substantially Equivalent on April 23, 1979, 46 days after the submission was received.

What is the product code of K790490?

The FDA product code is DBF – Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5340.