Ferritin Control - Level 1, 2, 3

FDA 510(k) K946266 · Clinical Controls, Inc.

Substantially Equivalent

510(k) numberK946266

Submission

Device name
Ferritin Control - Level 1, 2, 3
Applicant
Clinical Controls, Inc.
Grover Beach, CA, US
Received
December 23, 1994
Decision date
February 10, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DGD – Igg, Ferritin, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5510
Specialty
Immunology

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Questions and answers

When was Ferritin Control - Level 1, 2, 3 cleared by the FDA?

Ferritin Control - Level 1, 2, 3 (K946266) received a 510(k) decision of Substantially Equivalent on February 10, 1995, 49 days after the submission was received.

What is the product code of K946266?

The FDA product code is DGD – Igg, Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.