Cleared Traditional

CHLORIDE REAGENT KIT

K811319 · Chem-Elec, Inc. · Chemistry
Aug 1981
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K811319 is an FDA 510(k) clearance for the CHLORIDE REAGENT KIT, a Coulometric, Chloride (Class II — Special Controls, product code JFS), submitted by Chem-Elec, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1981, 93 days after receiving the submission on May 12, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K811319 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 1981
Decision Date August 13, 1981
Days to Decision 93 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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