Antinuclear Antibody Immunoglobulin Test System

FDA 510(k) K914550 · Diagnostic Resources, Inc.

Substantially Equivalent

510(k) numberK914550

Submission

Device name
Antinuclear Antibody Immunoglobulin Test System
Applicant
Diagnostic Resources, Inc.
Aurora, CO, US
Received
October 11, 1991
Decision date
February 11, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LKJ – Antinuclear Antibody, Antigen, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5100
Specialty
Immunology

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Questions and answers

When was Antinuclear Antibody Immunoglobulin Test System cleared by the FDA?

Antinuclear Antibody Immunoglobulin Test System (K914550) received a 510(k) decision of Substantially Equivalent on February 11, 1992, 123 days after the submission was received.

What is the product code of K914550?

The FDA product code is LKJ – Antinuclear Antibody, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.