FDA.reportPublic FDA data

510(k) K981467

Device
Amm
Applicant
ABBOTT LABORATORIES
510(k) number
K981467
Product code
JIF
Decision
Substantially Equivalent (SESE)
Decision date
1998-06-22
Date received
1998-04-23
Regulation
862.1065
Classification name
Enzymatic Method, Ammonia
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARK LITTLEFIELD
Address
1920 Hurd Dr. Irving TX US 75038 75038

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JIF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K183517Ammonia IIRoche Diagnostics Operations (Rdo)2019-02-08
K123677DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)Siemens Healthcare Diagnostics2013-03-07
K123320DIMENSION AMMONIA FLEX REAGENT CARTRIDGESiemens Healthcare Diagnostics2013-02-15
K062316DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGEDade Behring, Inc.2006-09-06
K051114SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAYSentinel Ch. Srl2005-11-25
K033921AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10Diagnostic Chemicals , Ltd.2004-03-10
K030873RANDOX AMMONIARandox Laboratories, Ltd.2003-05-12
K023841AMMONIA ASSAY FOR THE ADVIA 1650Bayer Diagnostics Corp.2002-12-24
K021151AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMBayer Diagnostics Corp.2002-07-13
K003196SYNCHRON SYSTEMS AMMONIA REAGENTBeckman Coulter, Inc.2000-12-22
K001285AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30Diagnostic Chemicals , Ltd.2000-06-02
K984402SYNCHRON SYSTEMS AMMONIA (AMM) REAGENTBeckman Coulter, Inc.1999-01-29
K981920AMMAbbott Laboratories1998-07-22
K974620AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)Trace America, Inc.1998-01-02
K964565PARAMAX AMMONIA AND AMMONIA BLANK REAGENTDade Intl., Inc.1996-11-22