Cleared Traditional

GENCHEM CO2 ACID REAGENT

K040975 · Genchem, Inc. · Chemistry
Dec 2004
Decision
257d
Days
Class 2
Risk

About This 510(k) Submission

K040975 is an FDA 510(k) clearance for the GENCHEM CO2 ACID REAGENT, a Ph Rate Measurement, Carbon-dioxide (Class II — Special Controls, product code JFL), submitted by Genchem, Inc. (Brea, US). The FDA issued a Cleared decision on December 27, 2004, 257 days after receiving the submission on April 14, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number K040975 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 2004
Decision Date December 27, 2004
Days to Decision 257 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JFL — Ph Rate Measurement, Carbon-dioxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1160

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