Cleared Traditional

CARESIDE CO2, TOTAL

K992475 · Careside, Inc. · Chemistry
Sep 1999
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K992475 is an FDA 510(k) clearance for the CARESIDE CO2, TOTAL, a Enzymatic, Carbon-dioxide (Class II — Special Controls, product code KHS), submitted by Careside, Inc. (Culver City, US). The FDA issued a Cleared decision on September 15, 1999, 51 days after receiving the submission on July 26, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number K992475 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 1999
Decision Date September 15, 1999
Days to Decision 51 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KHS — Enzymatic, Carbon-dioxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1160

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