FDA 510(k) Applications for Medical Device Product Code "CEJ"
(Tetraphenyl Borate, Colorimetry, Potassium)

FDA 510(k) Number Applicant Device Name Decision Date
K881440 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC IQ POTASSIUM 05/27/1988
K853404 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC QCA POTASSIUM TEST KIT 08/23/1985
K850258 BIOCLINICAL SYSTEMS, INC. BCS POTASSIUM TURBIDIMETRIC TEST 02/07/1985
K812677 BIODYNAMICS CORP. UNITEST-POTASSIUM 10/02/1981
K904033 BOEHRINGER MANNHEIM CORP. REFLOTRON POTASSIUM TEST TABS 11/06/1990
K813608 DIAGNOSTIC SPECIALTIES POTASSIUM REAGENT SET 01/22/1982
K880339 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST POTASSIUM K ITEM NUMBER 19XXX 02/25/1988
K811661 KING DIAGNOSTICS, INC. POTASSIUM TEST 06/25/1981
K832553 MALLINCKRODT CRITICAL CARE POTASSIUM TEST KIT 09/20/1983
K943026 PRISMA SYSTEMS POTASSIUM QVET 12/09/1994
K043267 RANDOX LABORATORIES, LTD. POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2 02/10/2005
K863486 SCLAVO, INC. POTASSIUM TEST 09/29/1986
K861713 STERLING DIAGNOSTICS, INC. SERUM POTASSIUM REAGENT SET 05/23/1986
K902574 TECH-CO, INC. POTASSIUM REAGENT SET 07/10/1990
K883585 TECHNICON INSTRUMENTS CORP. TECHNICON ASSIST POTASSIUM 11/29/1988
K883586 TECHNICON INSTRUMENTS CORP. TECHNICON RA-100 SYSTEM POTASSIUM 11/29/1988


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