Urine Diluent-For Use with Ion Selective Electrode

FDA 510(k) K860143 · Reagent Laboratory, Inc.

Substantially Equivalent

510(k) numberK860143

Submission

Device name
Urine Diluent-For Use with Ion Selective Electrode
Applicant
Reagent Laboratory, Inc.
Louisville, KY, US
Received
January 15, 1986
Decision date
February 10, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JJP – Electrode, Ion Selective (Non-Specified)
Device class
Class I (low risk)
Regulation
21 CFR 862.2050
Specialty
Clinical Chemistry

Other 510(k)s with product code JJP

510(k)DeviceApplicantDecision
K900280Centriprep 100JJP · Traditional Amicon, Inc.02/16/1990SE
K863438Nova II Sodium/Potassium/Lithium AnalyzerJJP · Traditional Nova Biomedical Corp.09/29/1986SE

More from Nova Biomedical Corp.

510(k)DeviceDecision
K863502Solution B- Na 50MEQ/L, K 40 Meq/LJIX · Traditional 10/21/1986SE
K863503HemolyseGGK · Traditional 10/03/1986SE
K863550Potassium Hydroxide 10% W/VPPM · Traditional 10/02/1986SE
K842982Formalin BufferedIFP · Traditional 10/01/1984SE
K843050Gram StainJTS · Traditional 09/11/1984SE
K842785Stain, Methylene Blue-EosinKFC · Traditional 09/11/1984SE
K841847Lithium ReagentJJO · Traditional 08/17/1984SE
K843051Wrights Stain Solution · Traditional 08/03/1984SESP
K841800Lysing & Hemoglobin ReagentGGK · Traditional 05/31/1984SE
K841799Cyanomethemoglobin ReagentGIF · Traditional 05/31/1984SE

Questions and answers

When was Urine Diluent-For Use with Ion Selective Electrode cleared by the FDA?

Urine Diluent-For Use with Ion Selective Electrode (K860143) received a 510(k) decision of Substantially Equivalent on February 10, 1986, 26 days after the submission was received.

What is the product code of K860143?

The FDA product code is JJP – Electrode, Ion Selective (Non-Specified), a Class I (low risk) device regulated under 21 CFR 862.2050.