Cleared Traditional

ELECYS IGE ASSAY

K984326 · Boehringer Mannheim Corp. · Immunology
Feb 1999
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K984326 is an FDA 510(k) clearance for the ELECYS IGE ASSAY, a Radioimmunoassay, Immunoglobulins (d, E) (Class II — Special Controls, product code JHR), submitted by Boehringer Mannheim Corp. (Indianapolis,, US). The FDA issued a Cleared decision on February 8, 1999, 67 days after receiving the submission on December 3, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K984326 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 1998
Decision Date February 08, 1999
Days to Decision 67 days
Submission Type Traditional
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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