Cleared Traditional

PARAMAX ELECTROLYTE CALIBRATOR

K863489 · American Dade · Chemistry
Sep 1986
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K863489 is an FDA 510(k) clearance for the PARAMAX ELECTROLYTE CALIBRATOR, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on September 29, 1986, 20 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 K863489 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 1986
Decision Date September 29, 1986
Days to Decision 20 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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