Cleared Traditional

NA/K FLUIDA PACK FOR NOVA 1 ANALYZER

K833712 · Fisher Scientific Co., LLC · Chemistry
Jan 1984
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K833712 is an FDA 510(k) clearance for the NA/K FLUIDA PACK FOR NOVA 1 ANALYZER, 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 January 13, 1984, 84 days after receiving the submission on October 21, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K833712 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 1983
Decision Date January 13, 1984
Days to Decision 84 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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