CEJ · Class II · 21 CFR 862.1600

FDA Product Code CEJ: Tetraphenyl Borate, Colorimetry, Potassium

Leading manufacturers include Technicon Instruments Corp., Bd Becton Dickinson Vacutainer Systems Preanalytic and Sclavo, Inc..

16
Total
16
Cleared
48d
Avg days
1981
Since

FDA 510(k) Cleared Tetraphenyl Borate, Colorimetry, Potassium Devices (Product Code CEJ)

16 devices
1–16 of 16
Cleared Feb 10, 2005
POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2
K043267
Randox Laboratories, Ltd.
Chemistry · 76d
Cleared Dec 09, 1994
POTASSIUM QVET
K943026
Prisma Systems
Chemistry · 165d
Cleared Nov 06, 1990
REFLOTRON POTASSIUM TEST TABS
K904033
Boehringer Mannheim Corp.
Chemistry · 67d
Cleared Jul 10, 1990
POTASSIUM REAGENT SET
K902574
Tech-Co, Inc.
Chemistry · 29d
Cleared Nov 29, 1988
TECHNICON ASSIST POTASSIUM
K883585
Technicon Instruments Corp.
Chemistry · 98d
Cleared Nov 29, 1988
TECHNICON RA-100 SYSTEM POTASSIUM
K883586
Technicon Instruments Corp.
Chemistry · 98d
Cleared May 27, 1988
IQ POTASSIUM
K881440
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 52d
Cleared Feb 25, 1988
EASY-TEST POTASSIUM K ITEM NUMBER 19XXX
K880339
Em Diagnostic Systems, Inc.
Chemistry · 30d
Cleared Sep 29, 1986
POTASSIUM TEST
K863486
Sclavo, Inc.
Chemistry · 20d
Cleared May 23, 1986
SERUM POTASSIUM REAGENT SET
K861713
Sterling Diagnostics, Inc.
Chemistry · 18d
Cleared Aug 23, 1985
QCA POTASSIUM TEST KIT
K853404
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 11d
Cleared Sep 20, 1983
POTASSIUM TEST KIT
K832553
Mallinckrodt Critical Care
Chemistry · 50d
Cleared Oct 02, 1981
UNITEST-POTASSIUM
K812677
Biodynamics Corp.
Chemistry · 10d
Cleared Jun 25, 1981
POTASSIUM TEST
K811661
King Diagnostics, Inc.
Chemistry · 10d

About Product Code CEJ - Regulatory Context