Cleared Traditional

ENZYMATIC CO2 REAGENT, MODIFICATION

K932267 · Intersect Systems, Inc. · Chemistry
Sep 1993
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K932267 is an FDA 510(k) clearance for the ENZYMATIC CO2 REAGENT, MODIFICATION, 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 September 24, 1993, 163 days after receiving the submission on April 14, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number K932267 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 1993
Decision Date September 24, 1993
Days to Decision 163 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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