Cleared Traditional

EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay

K173792 · Phadia AB · Immunology
Mar 2018
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K173792 is an FDA 510(k) clearance for the EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay, a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II — Special Controls, product code MOB), submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on March 13, 2018, 89 days after receiving the submission on December 14, 2017. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K173792 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 2017
Decision Date March 13, 2018
Days to Decision 89 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MOB — Test System, Antineutrophil Cytoplasmic Antibodies (anca)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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