SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY— 510(k) K051114

Name: FDA 510(k) clearance K051114
Creator: U.S. Food and Drug Administration
Published: 2005-11-25

Substantially Equivalent

Sentinel Ch. Srl

FDA 510(k) clearance K051114 for SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY, Substantially Equivalent on 2005-11-25. Applicant: Sentinel Ch. Srl. Device class: 1.

Clearance details

Applicant: Sentinel Ch. Srl
Product code: Code JIF
Device class: Class 1
Regulation: 21 CFR 862.1065
Advisory panel: Clinical Chemistry
Date received: 2005-05-02
Decision date: 2005-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milano, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code JIF

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K183517 — Ammonia II2019-02-08
K123677 — DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)2013-03-07
K123320 — DIMENSION AMMONIA FLEX REAGENT CARTRIDGE2013-02-15
K062316 — DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE2006-09-06
K033921 — AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-102004-03-10

More clearances from Sentinel Ch. Srl

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K070971 — MODIFICATION TO SENTINEL CLIN CHEM CAL2007-05-23
K051447 — SENTINEL PANCREATIC AMYLASE2006-01-26
K051111 — SENTINEL UIBC LIQUID2005-11-17
K051452 — SENTINEL CLIN CHEM CAL2005-10-25
K051456 — SENTINEL CERULOPLASMIN2005-10-21

Recalls naming K051114

K-number listed on FDA's recall record

Z-0164-2016 — Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.Class II·Terminated·Sentinel CH SpA·20150922

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051114.

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