Cleared Traditional

EliA Rib-P

K202540 · Phadia AB · Immunology
Sep 2021
Decision
376d
Days
Class 2
Risk

About This 510(k) Submission

K202540 is an FDA 510(k) clearance for the EliA Rib-P, a Anti-ribosomal P Antibodies (Class II — Special Controls, product code MQA), submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on September 13, 2021, 376 days after receiving the submission on September 2, 2020. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K202540 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 2020
Decision Date September 13, 2021
Days to Decision 376 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MQA — Anti-ribosomal P Antibodies
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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