Ferritin-Latex, Models 1418-2070, 1418-0279

FDA 510(k) K062746 · Medicon Hellas S.A

Substantially Equivalent

510(k) numberK062746

Submission

Device name
Ferritin-Latex, Models 1418-2070, 1418-0279
Applicant
Medicon Hellas S.A
Gerakas, Attiki, GR
Received
September 14, 2006
Decision date
November 20, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

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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Questions and answers

When was Ferritin-Latex, Models 1418-2070, 1418-0279 cleared by the FDA?

Ferritin-Latex, Models 1418-2070, 1418-0279 (K062746) received a 510(k) decision of Substantially Equivalent on November 20, 2006, 67 days after the submission was received.

What is the product code of K062746?

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