Cleared Traditional

CHLORIDE/CARBON DIOXIDE RATE REAGENT

K811701 · Chem-Elec, Inc. · Chemistry
Jul 1981
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K811701 is an FDA 510(k) clearance for the CHLORIDE/CARBON DIOXIDE RATE REAGENT, a Coulometric, Chloride (Class II — Special Controls, product code JFS), submitted by Chem-Elec, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 1, 1981, 15 days after receiving the submission on June 16, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K811701 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 1981
Decision Date July 01, 1981
Days to Decision 15 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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