CARBON DIOXIDE— 510(k) K060295

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K060295 for CARBON DIOXIDE, Substantially Equivalent on 2006-05-04. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code KHS
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 2006-02-06
Decision date: 2006-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K060295

K-number listed on FDA's recall record

Z-0575-2020 — Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island CanadaClass II·Terminated·Abbott GmBH & Co. KG·20191023

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060295.

Data sourced from openFDA. This site is unofficial and independent of the FDA.