Cleared Traditional

ABL90 FLEX ANALYZER

K131988 · Radiometer Medical Aps · Chemistry
Sep 2013
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K131988 is an FDA 510(k) clearance for the ABL90 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 September 17, 2013, 81 days after receiving the submission on June 28, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K131988 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2013
Decision Date September 17, 2013
Days to Decision 81 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

Similar Devices — CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

All 186
i-STAT CG4+ cartridge with the i-STAT 1 System
K244014 · Abbott Point of Care, Inc. · May 2025
ABL90 FLEX PLUS System
K240998 · Radiometer Medicals Aps · Dec 2024
i-STAT CG8+ cartridge with the i-STAT 1 System
K230285 · Abbott Point of Care, Inc. · Oct 2023
Stat Profile Prime Plus Analyzer System
K221900 · Nova Biomedical Corporation · Sep 2023
i-STAT G3+ cartridge with the i-STAT 1 System
K223857 · Abbott Point of Care, Inc. · Sep 2023
GEM Premier 7000 with IQM3
K223608 · Instrumentation Laboratory Company · Aug 2023