Cleared Traditional

Transferrin

K190495 · Biosystems S.A. · Immunology
Mar 2020
Decision
382d
Days
Class 2
Risk

About This 510(k) Submission

K190495 is an FDA 510(k) clearance for the Transferrin, a Transferrin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDG), submitted by Biosystems S.A. (Barcelona, ES). The FDA issued a Cleared decision on March 16, 2020, 382 days after receiving the submission on February 28, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5880.

Submission Details

510(k) Number K190495 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2019
Decision Date March 16, 2020
Days to Decision 382 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DDG — Transferrin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5880

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