Cleared Traditional

K812762 - IL 501, NA/K ANALYZER (FDA 510(k) Clearance)

Oct 1981
Decision
19d
Days
Class 2
Risk

K812762 is an FDA 510(k) clearance for the IL 501, NA/K ANALYZER. This device is classified as a Electrode, Ion Specific, Sodium (Class II - Special Controls, product code JGS).

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on October 20, 1981, 19 days after receiving the submission on October 1, 1981.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K812762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1981
Decision Date October 20, 1981
Days to Decision 19 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

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