Potassium Qvet

FDA 510(k) K943026 · Prisma Systems

Substantially Equivalent

510(k) numberK943026

Submission

Device name
Potassium Qvet
Applicant
Prisma Systems
Rome, NY, US
Received
June 27, 1994
Decision date
December 9, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CEJ – Tetraphenyl Borate, Colorimetry, Potassium
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1600
Specialty
Clinical Chemistry

Other 510(k)s with product code CEJ

510(k)DeviceApplicantDecision
K043267Potassium Test Kit and Electrolyte Cal 1 and 2CEJ · Traditional Randox Laboratories, Ltd.02/10/2005SE
K904033Reflotron Potassium Test TabsCEJ · Traditional Boehringer Mannheim Corp.11/06/1990SE
K902574Potassium Reagent SetCEJ · Traditional Tech-Co, Inc.07/10/1990SE
K883586Technicon RA-100 System PotassiumCEJ · Traditional Technicon Instruments Corp.11/29/1988SE
K883585Technicon Assist PotassiumCEJ · Traditional Technicon Instruments Corp.11/29/1988SE
K881440Iq PotassiumCEJ · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic05/27/1988SE
K880339Easy-Test Potassium K Item Number 19XXXCEJ · Traditional Em Diagnostic Systems, Inc.02/25/1988SE
K863486Potassium TestCEJ · Traditional Sclavo, Inc.09/29/1986SE
K861713Serum Potassium Reagent SetCEJ · Traditional Sterling Diagnostics, Inc.05/23/1986SE
K853404Qca Potassium Test KitCEJ · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic08/23/1985SE

More from Bd Becton Dickinson Vacutainer Systems Preanalytic

510(k)DeviceDecision
K950177CK QvetCGS · Traditional 03/03/1995SE
K943027Cholesterol QvetCHH · Traditional 01/27/1995SE
K943042Bun QvetCDN · Traditional 12/29/1994SE
K943001Magnesium QvetJGJ · Traditional 12/29/1994SE
K942997Alkaline Phosphatase (Alkp) QvetCJE · Traditional 12/29/1994SE
K942964Lactate Dehydrogenase QvetCFJ · Traditional 12/29/1994SE
K942963Glucose QvetCFR · Traditional 12/29/1994SE
K944102Ast QvetCIT · Traditional 12/13/1994SE
K943000Albumin QvetCIX · Traditional 12/13/1994SE
K943004Total Protein QvetCEK · Traditional 12/09/1994SE

Questions and answers

When was Potassium Qvet cleared by the FDA?

Potassium Qvet (K943026) received a 510(k) decision of Substantially Equivalent on December 9, 1994, 165 days after the submission was received.

What is the product code of K943026?

The FDA product code is CEJ – Tetraphenyl Borate, Colorimetry, Potassium, a Class II (moderate risk) device regulated under 21 CFR 862.1600.