Cleared Traditional

CARBON DIOXIDE REAGENT

K881169 · Intersect Systems, Inc. · Chemistry
Apr 1988
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K881169 is an FDA 510(k) clearance for the CARBON DIOXIDE REAGENT, a Enzymatic, Carbon-dioxide (Class II — Special Controls, product code KHS), submitted by Intersect Systems, Inc. (Longview, US). The FDA issued a Cleared decision on April 28, 1988, 41 days after receiving the submission on March 18, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number K881169 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 1988
Decision Date April 28, 1988
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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

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