Cleared Traditional

EIA SMDP IMMUNOASSAY

K132631 · Phadia US, Inc. · Immunology
Aug 2014
Decision
372d
Days
Class 2
Risk

About This 510(k) Submission

K132631 is an FDA 510(k) clearance for the EIA SMDP IMMUNOASSAY, a Anti-sm Antibody, Antigen And Control (Class II — Special Controls, product code LKP), submitted by Phadia US, Inc. (Portae, US). The FDA issued a Cleared decision on August 29, 2014, 372 days after receiving the submission on August 22, 2013. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K132631 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2013
Decision Date August 29, 2014
Days to Decision 372 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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