Cleared Traditional

N Latex FLC kappa, N Latex FLC lambda

K212379 · Siemens Healthcare Diagnostics Products GmbH · Immunology
Mar 2022
Decision
212d
Days
Class 2
Risk

About This 510(k) Submission

K212379 is an FDA 510(k) clearance for the N Latex FLC kappa, N Latex FLC lambda, a Kappa, Antigen, Antiserum, Control (Class II — Special Controls, product code DFH), submitted by Siemens Healthcare Diagnostics Products GmbH (Marburg, DE). The FDA issued a Cleared decision on March 2, 2022, 212 days after receiving the submission on August 2, 2021. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K212379 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2021
Decision Date March 02, 2022
Days to Decision 212 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DFH — Kappa, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5550

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