Cleared Traditional

REAGENTS CORNING CHLORIDE METER FOR

K830217 · Fisher Scientific Co., LLC · Chemistry
Feb 1983
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K830217 is an FDA 510(k) clearance for the REAGENTS CORNING CHLORIDE METER FOR, a Coulometric, Chloride (Class II — Special Controls, product code JFS), submitted by Fisher Scientific Co., LLC (Mchenry, US). The FDA issued a Cleared decision on February 18, 1983, 25 days after receiving the submission on January 24, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K830217 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 1983
Decision Date February 18, 1983
Days to Decision 25 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JFS — Coulometric, Chloride
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1170

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