Cleared Traditional

CARBON DIOXIDE LIQUID STABLE REAGENT

K070251 · Pointe Scientific, Inc., · Chemistry
Apr 2007
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K070251 is an FDA 510(k) clearance for the CARBON DIOXIDE LIQUID STABLE REAGENT, a Enzymatic, Carbon-dioxide (Class II — Special Controls, product code KHS), submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on April 30, 2007, 94 days after receiving the submission on January 26, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number K070251 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 2007
Decision Date April 30, 2007
Days to Decision 94 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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