CEO — Phosphomolybdate (Colorimetric), Inorganic Phosphorus Class I

FDA Device Classification

Classification Details

Product Code
CEO
Device Class
Class I
Regulation Number
862.1580
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K100263seppimELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTSMay 6, 2011
K072141alfa wassermann diagnostic technologiesS40 CLINICAL ANALYZER, S TEST IP, S TEST UAJune 24, 2008
K041643beckman coulterSYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENTAugust 18, 2004
K030015elan diagnosticsATAC PAK PHOSPHORUS REAGENTMarch 7, 2003
K022312abaxisPICCOLO PHOSPHORUS TEST SYSTEMSeptember 5, 2002
K013095wiener laboratories saicWIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311November 16, 2001
K003912jas diagnosticsPHOSPHORUS REAGENTFebruary 21, 2001
K003012hemagen diagnosticsRAICHEM PHOSPORUS REAGENTOctober 25, 2000
K991867a.p. total careINORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02August 2, 1999
K983503boehringer mannheimROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT December 1, 1998
K981769elan pharmaHICHEM PHOSPHORUS REAGENT KITJune 29, 1998
K981610caresideCARESIDE ANALYZERJune 25, 1998
K981759abbott laboratoriesPHOSJune 16, 1998
K981118abbott laboratoriesPHOSJune 12, 1998
K974858diagnostic chemicalsPHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30January 30, 1998
K974605randox laboratoriesRANDOX INORGANIC PHOSPHOROUSJanuary 9, 1998
K971363carolina liquid chemistriesSYNCHRON CX SYSTEMS PHOSPHORUS REAGENTApril 21, 1997
K955937derma media labINORGANIC PHOSPHORUS REAGENTMarch 12, 1996
K944768olympus americaOLYMPUS INORGANIC PHOSPHORUS REAGENTMarch 24, 1995
K942960prisma systemsPHOSPHATE QVETDecember 9, 1994