Cleared Abbreviated

ABL837 FLEX ANALYZER

K100777 · Radiometer Medical Aps · Chemistry
Dec 2010
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K100777 is an FDA 510(k) clearance for the ABL837 FLEX ANALYZER, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Radiometer Medical Aps (Bronshoj, DK). The FDA issued a Cleared decision on December 10, 2010, 267 days after receiving the submission on March 18, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K100777 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2010
Decision Date December 10, 2010
Days to Decision 267 days
Submission Type Abbreviated
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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