AMMONIA ASSAY FOR THE ADVIA 1650— 510(k) K023841

Name: FDA 510(k) clearance K023841
Creator: U.S. Food and Drug Administration
Published: 2002-12-24

Substantially Equivalent

Bayer Diagnostics Corp.

FDA 510(k) clearance K023841 for AMMONIA ASSAY FOR THE ADVIA 1650, Substantially Equivalent on 2002-12-24. Applicant: Bayer Diagnostics Corp.. Device class: 1.

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: Code JIF
Device class: Class 1
Regulation: 21 CFR 862.1065
Advisory panel: Clinical Chemistry
Date received: 2002-11-18
Decision date: 2002-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JIF

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K123320 — DIMENSION AMMONIA FLEX REAGENT CARTRIDGE2013-02-15
K062316 — DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE2006-09-06
K051114 — SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY2005-11-25

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K031857 — ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY2003-09-04
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Recalls naming K023841

K-number listed on FDA's recall record

Z-1646-2018 — ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA). Product Number: 10286035 (Mfr: Randox Laboratories)Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20170629

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K023841.

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