Cleared Special

RAICHEM CO2 REAGENT

K982056 · Reagents Applications, Inc. · Chemistry
Jun 1998
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K982056 is an FDA 510(k) clearance for the RAICHEM CO2 REAGENT, a Enzymatic, Carbon-dioxide (Class II — Special Controls, product code KHS), submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on June 24, 1998, 15 days after receiving the submission on June 9, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number K982056 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 1998
Decision Date June 24, 1998
Days to Decision 15 days
Submission Type Special
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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