Cleared Traditional

Elecsys CA 15-3 II

K181492 · Roche Diagnostics · Immunology
Jun 2018
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K181492 is an FDA 510(k) clearance for the Elecsys CA 15-3 II, a System, Test, Immunological, Antigen, Tumor (Class II — Special Controls, product code MOI), submitted by Roche Diagnostics (Indianpolis, US). The FDA issued a Cleared decision on June 22, 2018, 16 days after receiving the submission on June 6, 2018. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K181492 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 2018
Decision Date June 22, 2018
Days to Decision 16 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MOI — System, Test, Immunological, Antigen, Tumor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

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