Cleared Traditional

STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ

K843452 · Fisher Scientific Co., LLC · Chemistry
Sep 1984
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K843452 is an FDA 510(k) clearance for the STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ, a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Fisher Scientific Co., LLC (Mchenry, US). The FDA issued a Cleared decision on September 27, 1984, 22 days after receiving the submission on September 5, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K843452 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 1984
Decision Date September 27, 1984
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JGS — Electrode, Ion Specific, Sodium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1665

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