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510(k) K944768

Device
OLYMPUS INORGANIC PHOSPHORUS REAGENT
Applicant
OLYMPUS AMERICA, INC.
510(k) number
K944768
Product code
CEO  
Decision
Substantially Equivalent (SESE)
Decision date
1995-03-24
Date received
1994-09-27
Regulation
862.1580
Classification name
Phosphomolybdate (colorimetric), Inorganic Phosphorus
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
LAURA STORMS-TYLER
Address
4 Nevada Dr. Lake Success NY US 11042 11042

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CEO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K100263ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTSSeppim S.A.S.2011-05-06
K072141S40 CLINICAL ANALYZER, S TEST IP, S TEST UAAlfa Wassermann Diagnostic Technologies, Inc.2008-06-24
K041643SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENTBeckman Coulter, Inc.2004-08-18
K030015ATAC PAK PHOSPHORUS REAGENTElan Diagnostics2003-03-07
K022312PICCOLO PHOSPHORUS TEST SYSTEMAbaxis, Inc.2002-09-05
K013095WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311Wiener Laboratories Saic2001-11-16
K003912PHOSPHORUS REAGENTJas Diagnostics, Inc.2001-02-21
K003012RAICHEM PHOSPORUS REAGENTHemagen Diagnostics, Inc.2000-10-25
K991867INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02A.P. Total Care, Inc.1999-08-02
K983503ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347Boehringer Mannheim Corp.1998-12-01
K981769HICHEM PHOSPHORUS REAGENT KITElan Pharma, Inc.1998-06-29
K981610CARESIDE ANALYZERCareside, Inc.1998-06-25
K981759PHOSAbbott Laboratories1998-06-16
K981118PHOSAbbott Laboratories1998-06-12
K974858PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30Diagnostic Chemicals , Ltd.1998-01-30

Legacy Summary#

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FDA Review#

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