Cleared Special

ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE

K992859 · Radiometer America, Inc. · Chemistry
Jan 2000
Decision
138d
Days
Class 2
Risk

About This 510(k) Submission

K992859 is an FDA 510(k) clearance for the ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Radiometer America, Inc. (Westlake, US). The FDA issued a Cleared decision on January 10, 2000, 138 days after receiving the submission on August 25, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K992859 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 1999
Decision Date January 10, 2000
Days to Decision 138 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CHL — Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1120

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