Cleared Traditional

SUPREME II CONTROL SOLUTIONS

K983432 · Chronimed, Inc. · Chemistry
Dec 1998
Decision
79d
Days
Class 1
Risk

About This 510(k) Submission

K983432 is an FDA 510(k) clearance for the SUPREME II CONTROL SOLUTIONS, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Chronimed, Inc. (Minnetonka, US). The FDA issued a Cleared decision on December 17, 1998, 79 days after receiving the submission on September 29, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K983432 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 1998
Decision Date December 17, 1998
Days to Decision 79 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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