Cleared Traditional

RERMCO TEST CHLORIDE REAGENT

K823106 · Fermco Biochemics, Inc. · Chemistry
Nov 1982
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K823106 is an FDA 510(k) clearance for the RERMCO TEST CHLORIDE REAGENT, a Coulometric, Chloride (Class II — Special Controls, product code JFS), submitted by Fermco Biochemics, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1982, 26 days after receiving the submission on October 21, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K823106 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 1982
Decision Date November 16, 1982
Days to Decision 26 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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