Cleared Traditional

ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM

K980130 · Radiometer America, Inc. · Chemistry
Feb 1998
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K980130 is an FDA 510(k) clearance for the ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM, 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 February 9, 1998, 26 days after receiving the submission on January 14, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K980130 FDA.gov
FDA Decision Cleared SESE
Date Received January 14, 1998
Decision Date February 09, 1998
Days to Decision 26 days
Submission Type Traditional
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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