Cleared Traditional

EliA RF IgM Immunoassay

K182747 · Phadia AB · Immunology
Dec 2018
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K182747 is an FDA 510(k) clearance for the EliA RF IgM Immunoassay, a System, Test, Rheumatoid Factor (Class II — Special Controls, product code DHR), submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on December 18, 2018, 81 days after receiving the submission on September 28, 2018. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number K182747 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2018
Decision Date December 18, 2018
Days to Decision 81 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DHR — System, Test, Rheumatoid Factor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5775

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