Home / Device Classification / CEK

CEK — Biuret (Colorimetric), Total Protein Class II

FDA Device Classification

Classification Details

Product Code
CEK
Device Class
Class II
Regulation Number
862.1635
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K992846elan holdingsHICHEM TOTAL PROTEIN REAGENTOctober 18, 1999
K973108diagnostic chemicalsTOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50March 2, 1998
K980042exigent diagnosticsCARESIDE TOTAL PROTEINFebruary 4, 1998
K971524carolina liquid chemistriesTOTAL PROTEIN OR TPMay 16, 1997
K961864teco diagnosticsCSF/URINE TOTAL PROTEINOctober 24, 1996
K955905solarcare technologies corpSTC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAYMay 30, 1996
K955936derma media labTOTAL PROTEIN REAGENTMarch 12, 1996
K950920dupont medical productsDUPONT DIMENSION TOTAL PROTEIN METHODAugust 11, 1995
K950234emd chemicalsTOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2June 14, 1995
K950128emd chemicalsTOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2May 15, 1995
K943004prisma systemsTOTAL PROTEIN QVETDecember 9, 1994
K941496solarcareSOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAYOctober 27, 1994
K942424data medical associatesDMA MICROPROTEIN PROCEDURESeptember 6, 1994
K934841e.i. dupont de nemours and coURINARY/CEREBROSPINAL FLUID PROTEINApril 6, 1994
K935174em diagnostic systemsTOTAL PROTEIN TEST (TPRO)December 16, 1993
K921412sterling diagnosticsMICROPROTEIN REAGENT SETJanuary 21, 1993
K924659olympusOLYUMPUS TOTAL PROTEIN REAGENTDecember 29, 1992
K922467beckman instrumentsSYNCHRON TOTAL PROTEIN TEST --MODIFIEDNovember 23, 1992
K923267em diagnostic systemsSYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000September 9, 1992
K923266nova biomedicalNOVA TOTAL PROTEIN MODULEAugust 12, 1992