Cleared Special

ELECSYS IGE II IMMUNOASSAY

K061970 · Roche Diagnostics · Immunology
Aug 2006
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K061970 is an FDA 510(k) clearance for the ELECSYS IGE II IMMUNOASSAY, a Radioimmunoassay, Immunoglobulins (d, E) (Class II — Special Controls, product code JHR), submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on August 31, 2006, 50 days after receiving the submission on July 12, 2006. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K061970 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 2006
Decision Date August 31, 2006
Days to Decision 50 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JHR — Radioimmunoassay, Immunoglobulins (d, E)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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