Cleared Traditional

SOLUTION B- NA 50MEQ/L, K 40 MEQ/L

K863502 · Reagent Laboratory, Inc. · Chemistry
Oct 1986
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K863502 is an FDA 510(k) clearance for the SOLUTION B- NA 50MEQ/L, K 40 MEQ/L, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Reagent Laboratory, Inc. (Louisville, US). The FDA issued a Cleared decision on October 21, 1986, 42 days after receiving the submission on September 9, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K863502 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 1986
Decision Date October 21, 1986
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JIX — Calibrator, Multi-analyte Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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