Chem-Pro 1000 Clinical Chemistry-Analysis Sys

FDA 510(k) K855091 · Sen Tech Medical Corp.

Substantially Equivalent

510(k) numberK855091

Submission

Device name
Chem-Pro 1000 Clinical Chemistry-Analysis Sys
Applicant
Sen Tech Medical Corp.
Arden Hills, MN, US
Received
December 20, 1985
Decision date
March 14, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CDS – Electrode, Ion Specific, Urea Nitrogen
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1770
Specialty
Clinical Chemistry

Other 510(k)s with product code CDS

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K171247epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide TestCDS · Traditional Epocal, Inc.01/17/2018SE
K040973Bun ReagentCDS · Traditional Genchem, Inc.12/27/2004SE
K033056Bun Reagent for Beckman Synchron CX & CX Delta ReagentCDS · Traditional Diamond Diagnostics, Inc.01/30/2004SE
K925550Hi Chem Bun Reagent Kit,Product Number 88806CDS · Traditional Hichem Diagnostics04/20/1993SE
K860543Blood Urea Nitrogen (Bun) TestcardCDS · Traditional Ilex Corp.04/21/1986SE
K812308Lancer Bun Rate Reagent KitCDS · Traditional Sherwood Medical Co.08/31/1981SE
K811193Bun Rate ReagentCDS · Traditional Chem-Elec, Inc.07/10/1981SE
K800616Bun Reagent Kit #88108CDS · Traditional Hi Chem, Inc.04/10/1980SE
K800590Bun KitCDS · Traditional Nobel Scientific Industries, Inc.04/04/1980SE
K800071Bun Reagent KitCDS · Traditional Fisher Scientific Co., LLC02/05/1980SE

More from Fisher Scientific Co., LLC

510(k)DeviceDecision
K910071Porta Gas Compressed Gas Cylinder CartGET · Traditional 03/22/1991SE
K854260Chempro 1000CGA · Traditional 11/19/1985SE
K851100Chem Pro 1000 Chemistry AnalysisCEM · Traditional 07/09/1985SE
K841575Sentech's Ulab 1000 Clinical Chem.CEM · Traditional 07/06/1984SE

Questions and answers

When was Chem-Pro 1000 Clinical Chemistry-Analysis Sys cleared by the FDA?

Chem-Pro 1000 Clinical Chemistry-Analysis Sys (K855091) received a 510(k) decision of Substantially Equivalent on March 14, 1986, 84 days after the submission was received.

What is the product code of K855091?

The FDA product code is CDS – Electrode, Ion Specific, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.