Cleared Traditional

EASYLYTE CALCIUM/CHLORIDE ANALYZER

K963694 · Medica Corp. · Chemistry
Nov 1996
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K963694 is an FDA 510(k) clearance for the EASYLYTE CALCIUM/CHLORIDE ANALYZER, a Electrode, Ion Specific, Calcium (Class II — Special Controls, product code JFP), submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on November 27, 1996, 72 days after receiving the submission on September 16, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K963694 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 1996
Decision Date November 27, 1996
Days to Decision 72 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JFP — Electrode, Ion Specific, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145

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