Cleared Special

MODIFICATION TO ABL800 FLEX

K050869 · Radiometer Medical Aps · Chemistry
Aug 2005
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K050869 is an FDA 510(k) clearance for the MODIFICATION TO ABL800 FLEX, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Radiometer Medical Aps (Washington, US). The FDA issued a Cleared decision on August 11, 2005, 127 days after receiving the submission on April 6, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K050869 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 2005
Decision Date August 11, 2005
Days to Decision 127 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CIG — Diazo Colorimetry, Bilirubin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1110

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