Cleared Traditional

ELECTROLYTE CONTROL

K912513 · Verichem Laboratories, Inc. · Chemistry
Jul 1991
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K912513 is an FDA 510(k) clearance for the ELECTROLYTE CONTROL, a Electrolyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJR), submitted by Verichem Laboratories, Inc. (Providence, US). The FDA issued a Cleared decision on July 19, 1991, 43 days after receiving the submission on June 6, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K912513 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 1991
Decision Date July 19, 1991
Days to Decision 43 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJR — Electrolyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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