Cleared Traditional

CARESIDE ANALYZER

K993634 · Careside, Inc. · Chemistry
Dec 1999
Decision
36d
Days
Class 1
Risk

About This 510(k) Submission

K993634 is an FDA 510(k) clearance for the CARESIDE ANALYZER, a Analyzer, Chemistry, Micro, For Clinical Use (Class I — General Controls, product code JJF), submitted by Careside, Inc. (Culver City, US). The FDA issued a Cleared decision on December 2, 1999, 36 days after receiving the submission on October 27, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2170.

Submission Details

510(k) Number K993634 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 1999
Decision Date December 02, 1999
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJF — Analyzer, Chemistry, Micro, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2170

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