Cleared Traditional

HICHEM ISE ELECTROLYTE REFERENCE

K992842 · Elan Holdings, Inc. · Chemistry
Nov 1999
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K992842 is an FDA 510(k) clearance for the HICHEM ISE ELECTROLYTE REFERENCE, a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Elan Holdings, Inc. (Brea, US). The FDA issued a Cleared decision on November 26, 1999, 94 days after receiving the submission on August 24, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K992842 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 1999
Decision Date November 26, 1999
Days to Decision 94 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JGS — Electrode, Ion Specific, Sodium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1665

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