ClearanceBrief
Panels › Clinical Chemistry › Product code CEJ · Class 2

Tetraphenyl Borate, Colorimetry, Potassium

Regulation 862.1600

0510(k)s in 12 months (16 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in CEJ

Company510(k)sRecalls
Bd Becton Dickinson Vacutainer Systems Preanalytic20
Technicon Instruments Corp.20
Bioclinical Systems, Inc.10
Biodynamics Corp.10
Boehringer Mannheim Corp.10
Diagnostic Specialties10
Em Diagnostic Systems, Inc.10
King Diagnostics, Inc.10
Mallinckrodt Critical Care10
Prisma Systems10
Decided510(k)Device and applicantCode
Feb 10, 2005K043267POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2
Randox Laboratories, Ltd., GB
CEJ
Dec 9, 1994K943026POTASSIUM QVET
Prisma Systems
CEJ
Nov 6, 1990K904033REFLOTRON POTASSIUM TEST TABS
Boehringer Mannheim Corp.
CEJ
Jul 10, 1990K902574POTASSIUM REAGENT SET
Tech-Co, Inc.
CEJ
Nov 29, 1988K883586TECHNICON RA-100 SYSTEM POTASSIUM
Technicon Instruments Corp.
CEJ
Nov 29, 1988K883585TECHNICON ASSIST POTASSIUM
Technicon Instruments Corp.
CEJ
May 27, 1988K881440IQ POTASSIUM
Bd Becton Dickinson Vacutainer Systems Preanalytic
CEJ
Feb 25, 1988K880339EASY-TEST POTASSIUM K ITEM NUMBER 19XXX
Em Diagnostic Systems, Inc.
CEJ
Sep 29, 1986K863486POTASSIUM TEST
Sclavo, Inc.
CEJ
May 23, 1986K861713SERUM POTASSIUM REAGENT SET
Sterling Diagnostics, Inc.
CEJ
Aug 23, 1985K853404QCA POTASSIUM TEST KIT
Bd Becton Dickinson Vacutainer Systems Preanalytic
CEJ
Feb 7, 1985K850258BCS POTASSIUM TURBIDIMETRIC TEST
Bioclinical Systems, Inc.
CEJ
Sep 20, 1983K832553POTASSIUM TEST KIT
Mallinckrodt Critical Care
CEJ
Jan 22, 1982K813608POTASSIUM REAGENT SET
Diagnostic Specialties
CEJ
Oct 2, 1981K812677UNITEST-POTASSIUM
Biodynamics Corp.
CEJ
Jun 25, 1981K811661POTASSIUM TEST
King Diagnostics, Inc.
CEJ

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