Cleared Traditional

CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000

K990036 · Careside, Inc. · Chemistry
Mar 1999
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K990036 is an FDA 510(k) clearance for the CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000, a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Careside, Inc. (Culver City, US). The FDA issued a Cleared decision on March 18, 1999, 71 days after receiving the submission on January 6, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K990036 FDA.gov
FDA Decision Cleared SESE
Date Received January 06, 1999
Decision Date March 18, 1999
Days to Decision 71 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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