Neia Transferrin Enzymeimmunoassay

FDA 510(k) K813288 · New England Immunology Assoc.

Substantially Equivalent

510(k) numberK813288

Submission

Device name
Neia Transferrin Enzymeimmunoassay
Applicant
New England Immunology Assoc.
Mchenry, IL, US
Received
November 23, 1981
Decision date
December 17, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DDG – Transferrin, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5880
Specialty
Immunology

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More from Dade Behring, Inc.

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K811757Neia Pap EnzymeimmunoassayJFH · Traditional 08/13/1981SE
K790490Neia-Ferritin Enzymeimmunassay KitDBF · Traditional 04/23/1979SE
K780490Neia-Ferritin EnzymeimmunoassayDBF · Traditional 04/10/1978SE

Questions and answers

When was Neia Transferrin Enzymeimmunoassay cleared by the FDA?

Neia Transferrin Enzymeimmunoassay (K813288) received a 510(k) decision of Substantially Equivalent on December 17, 1981, 24 days after the submission was received.

What is the product code of K813288?

The FDA product code is DDG – Transferrin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5880.