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CED — 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase Class I

FDA Device Classification

Classification Details

Product Code
CED
Device Class
Class I
Regulation Number
862.1520
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K894288em diagnostic systemsPHOSPHORUS TEST ITEM NUMBER 65416August 31, 1989
K840151eastman kodakEKTACHEM CLINICAL CHEM. SLIDESMarch 22, 1984
K833710btc diagnosticsBTC URINE LH ASSAYJanuary 30, 1984
K820832american monitorPHOSPHORUS ILApril 15, 1982
K812670sandare chemical coSANDARE FAST 340 PHOSPHORUS PROCEDUREOctober 2, 1981
K811864sigma chemicalSIGMA PROCEDURE 265-UVJuly 31, 1981
K811222connecticut diagnosticsINORGANIC PHOSPHORUS REAGENTSMay 21, 1981
K802420union carbideCENTRIFICHEM INORGANIC PHOSPHORUSOctober 31, 1980
K790662union carbideCENTRIFICHEM INORGANIC PHOSPHORUSMay 15, 1979