Cleared Traditional

EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816

K990971 · Medica Corp. · Chemistry
Apr 1999
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K990971 is an FDA 510(k) clearance for the EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816, a Electrolyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJR), submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on April 27, 1999, 35 days after receiving the submission on March 23, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K990971 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 1999
Decision Date April 27, 1999
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJR — Electrolyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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