Cleared Traditional

K841610 - COMPONENTS FOR POTASSIUM, SODIUM CHLO
(FDA 510(k) Clearance)

May 1984
Decision
46d
Days
Class 2
Risk

K841610 is an FDA 510(k) clearance for the COMPONENTS FOR POTASSIUM, SODIUM CHLO. This device is classified as a Flame Photometry, Sodium (Class II - Special Controls, product code JGT).

Submitted by Shaban Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on May 25, 1984, 46 days after receiving the submission on April 9, 1984.

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

Submission Details

510(k) Number K841610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1984
Decision Date May 25, 1984
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

Product Code JGT — Flame Photometry, Sodium
Device Class Class II - Special Controls
CFR Regulation 21 CFR 862.1665

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