Cleared Traditional

EliA SmDP Immunoassay

K183007 · Phadia AB · Immunology
Dec 2018
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K183007 is an FDA 510(k) clearance for the EliA SmDP Immunoassay, a Anti-sm Antibody, Antigen And Control (Class II — Special Controls, product code LKP), submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on December 24, 2018, 54 days after receiving the submission on October 31, 2018. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K183007 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2018
Decision Date December 24, 2018
Days to Decision 54 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LKP — Anti-sm Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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