Cleared Traditional

ELECSYS IGE CALCHECK

K984419 · Boehringer Mannheim Corp. · Immunology
Feb 1999
Decision
54d
Days
Class 1
Risk

About This 510(k) Submission

K984419 is an FDA 510(k) clearance for the ELECSYS IGE CALCHECK, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Boehringer Mannheim Corp. (Indianapolis,, US). The FDA issued a Cleared decision on February 2, 1999, 54 days after receiving the submission on December 10, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K984419 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 1998
Decision Date February 02, 1999
Days to Decision 54 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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