Auraflex Ferritin 200 Test Pack 80500, Auraflex Ferritin Calibrator Pack 80501

FDA 510(k) K974505 · Alfa Biotech (Uk) , Ltd.

Substantially Equivalent

510(k) numberK974505

Submission

Device name
Auraflex Ferritin 200 Test Pack 80500, Auraflex Ferritin Calibrator Pack 80501
Applicant
Alfa Biotech (Uk) , Ltd.
Aldershot Hants, GB
Received
December 1, 1997
Decision date
February 17, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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.

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K980574Auraflex TSH-3 200 Test Pack Model Number 80600, Auraflex TSH-3 Calibrator Pack Model…JLW · Traditional 03/24/1998SE
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Questions and answers

When was Auraflex Ferritin 200 Test Pack 80500, Auraflex Ferritin Calibrator Pack 80501 cleared by the FDA?

Auraflex Ferritin 200 Test Pack 80500, Auraflex Ferritin Calibrator Pack 80501 (K974505) received a 510(k) decision of Substantially Equivalent on February 17, 1998, 78 days after the submission was received.

What is the product code of K974505?

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