FDA 510(k) Applications for Medical Device Product Code "CEO"
(Phosphomolybdate (Colorimetric), Inorganic Phosphorus)

FDA 510(k) Number Applicant Device Name Decision Date
K991867 A.P. TOTAL CARE, INC. INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 08/02/1999
K022312 ABAXIS, INC. PICCOLO PHOSPHORUS TEST SYSTEM 09/05/2002
K981118 ABBOTT LABORATORIES PHOS 06/12/1998
K981759 ABBOTT LABORATORIES PHOS 06/16/1998
K072141 ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. S40 CLINICAL ANALYZER, S TEST IP, S TEST UA 06/24/2008
K041643 BECKMAN COULTER, INC. SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT 08/18/2004
K983503 BOEHRINGER MANNHEIM CORP. ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 12/01/1998
K981610 CARESIDE, INC. CARESIDE ANALYZER 06/25/1998
K971363 CAROLINA LIQUID CHEMISTRIES CORP. SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT 04/21/1997
K955937 DERMA MEDIA LAB., INC. INORGANIC PHOSPHORUS REAGENT 03/12/1996
K974858 DIAGNOSTIC CHEMICALS LTD. PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30 01/30/1998
K030015 ELAN DIAGNOSTICS ATAC PAK PHOSPHORUS REAGENT 03/07/2003
K981769 ELAN PHARMA, INC. HICHEM PHOSPHORUS REAGENT KIT 06/29/1998
K003012 HEMAGEN DIAGNOSTICS, INC. RAICHEM PHOSPORUS REAGENT 10/25/2000
K003912 JAS Diagnostics, Inc. PHOSPHORUS REAGENT 02/21/2001
K974605 RANDOX LABORATORIES, LTD. RANDOX INORGANIC PHOSPHOROUS 01/09/1998
K100263 SEPPIM S.A.S. ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS 05/06/2011
K013095 WIENER LABORATORIES S.A.I.C. WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311 11/16/2001


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