Cleared Traditional

EliA SmDP-S

K202067 · Phadia AB · Immunology
Jul 2021
Decision
352d
Days
Class 2
Risk

About This 510(k) Submission

K202067 is an FDA 510(k) clearance for the EliA SmDP-S, 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 July 14, 2021, 352 days after receiving the submission on July 27, 2020. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K202067 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 2020
Decision Date July 14, 2021
Days to Decision 352 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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