SENTINEL CHOLINESTERASE LIQUID— 510(k) K051444

Name: FDA 510(k) clearance K051444
Creator: U.S. Food and Drug Administration
Published: 2005-06-20

Substantially Equivalent

Sentinel Ch. Srl

FDA 510(k) clearance K051444 for SENTINEL CHOLINESTERASE LIQUID, Substantially Equivalent on 2005-06-20. Applicant: Sentinel Ch. Srl. Device class: 1.

Clearance details

Applicant: Sentinel Ch. Srl
Product code: Code DIH
Device class: Class 1
Regulation: 21 CFR 862.3240
Advisory panel: Clinical Toxicology
Date received: 2005-06-02
Decision date: 2005-06-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Milano, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code DIH

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K103373 — SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A537222011-02-07
K061093 — CHOLINESTERASE GEN.2 TEST SYSTEM2006-07-03
K030045 — OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)2003-02-21
K023992 — WIENER LAB COLINESTERASA AA2003-02-12
K013750 — ADVIA 1650 CHOLINESTERASE ASSAY2002-01-18

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
K051114 — SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY2005-11-25
K051111 — SENTINEL UIBC LIQUID2005-11-17
K051452 — SENTINEL CLIN CHEM CAL2005-10-25

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