Cleared Traditional

ADVIA IMS

K001344 · Bayer Corp. · Chemistry
Jun 2000
Decision
60d
Days
Class 1
Risk

About This 510(k) Submission

K001344 is an FDA 510(k) clearance for the ADVIA IMS, a Colorimetry, Cholinesterase (Class I — General Controls, product code DIH), submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on June 26, 2000, 60 days after receiving the submission on April 27, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3240.

Submission Details

510(k) Number K001344 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 2000
Decision Date June 26, 2000
Days to Decision 60 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DIH — Colorimetry, Cholinesterase
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3240

Similar Devices — DIH Colorimetry, Cholinesterase

All 25
SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722
K103373 · Beckman Coulter, Inc. · Feb 2011
CHOLINESTERASE GEN.2 TEST SYSTEM
K061093 · Roche Diagnostics Corp. · Jul 2006
SENTINEL CHOLINESTERASE LIQUID
K051444 · Sentinel Ch. Srl · Jun 2005
OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)
K030045 · Olympus America, Inc. · Feb 2003
WIENER LAB COLINESTERASA AA
K023992 · Wiener Laboratories Saic · Feb 2003
ADVIA 1650 CHOLINESTERASE ASSAY
K013750 · Bayer Diagnostics Corp. · Jan 2002