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510(k) K943026

Device
POTASSIUM QVET
Applicant
PRISMA SYSTEMS
510(k) number
K943026
Product code
CEJ  
Decision
Substantially Equivalent (SESE)
Decision date
1994-12-09
Date received
1994-06-27
Regulation
862.1600
Classification name
Tetraphenyl Borate, Colorimetry, Potassium
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LARRY BEASLEY
Address
1721 Black River Blvd. Rome NY US 13440 13440

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CEJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K043267POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2Randox Laboratories, Ltd.2005-02-10
K904033REFLOTRON POTASSIUM TEST TABSBoehringer Mannheim Corp.1990-11-06
K902574POTASSIUM REAGENT SETTech-Co, Inc.1990-07-10
K883585TECHNICON ASSIST POTASSIUMTechnicon Instruments Corp.1988-11-29
K883586TECHNICON RA-100 SYSTEM POTASSIUMTechnicon Instruments Corp.1988-11-29
K881440IQ POTASSIUMBd Becton Dickinson Vacutainer Systems Preanalytic1988-05-27
K880339EASY-TEST POTASSIUM K ITEM NUMBER 19XXXEm Diagnostic Systems, Inc.1988-02-25
K863486POTASSIUM TESTSclavo, Inc.1986-09-29
K861713SERUM POTASSIUM REAGENT SETSterling Diagnostics, Inc.1986-05-23
K853404QCA POTASSIUM TEST KITBd Becton Dickinson Vacutainer Systems Preanalytic1985-08-23
K850258BCS POTASSIUM TURBIDIMETRIC TESTBioclinical Systems, Inc.1985-02-07
K832553POTASSIUM TEST KITMallinckrodt Critical Care1983-09-20
K813608POTASSIUM REAGENT SETDiagnostic Specialties1982-01-22
K812677UNITEST-POTASSIUMBiodynamics Corp.1981-10-02
K811661POTASSIUM TESTKing Diagnostics, Inc.1981-06-25

Legacy Summary#

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FDA Review#

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