Product Code: CDS FDA class 2 21 CFR 862.1770

Electrode, Ion Specific, Urea Nitrogen

Clinical Chemistry

The Ion-Specific Electrode Urea Nitrogen Test is a clinical chemistry device that measures urea nitrogen concentration in blood using an ion-selective electrode, which detects ammonium ions produced by enzymatic hydrolysis of urea, providing a rapid and accurate method for assessing renal function. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CDS, regulated under 21 CFR 862.1770, within the Clinical Chemistry medical specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

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Unique Applicants

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Basic Information

Product Code: CDS
Device Class: FDA class 2
Regulation Number: 862.1770
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 15 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K171247	epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test	Jan 17, 2018	Substantially Equivalent	Epocal, Inc.
K040973	BUN REAGENT	Dec 27, 2004	Substantially Equivalent	Genchem, Inc.
K033056	BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT	Jan 30, 2004	Substantially Equivalent	Diamond Diagnostics, Inc.
K925550	HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806	Apr 20, 1993	Substantially Equivalent	Hichem Diagnostics
K860543	BLOOD UREA NITROGEN (BUN) TESTCARD	Apr 21, 1986	Substantially Equivalent	Ilex Corp.
K855091	CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS	Mar 14, 1986	Substantially Equivalent	Sen Tech Medical Corp.
K812308	LANCER BUN RATE REAGENT KIT	Aug 31, 1981	Substantially Equivalent	Sherwood Medical Co.
K811193	BUN RATE REAGENT	Jul 10, 1981	Substantially Equivalent	Chem-Elec, Inc.
K800616	BUN REAGENT KIT #88108	Apr 10, 1980	Substantially Equivalent	Hi Chem, Inc.
K800590	BUN KIT	Apr 04, 1980	Substantially Equivalent	Nobel Scientific Industries, Inc.
K800071	BUN REAGENT KIT	Feb 05, 1980	Substantially Equivalent	Fisher Scientific Co., LLC
K791018	FERMCOTEST R BUN RATE REAGENT TEST KIT	Jul 17, 1979	Substantially Equivalent	Fermco Biochemics, Inc.
K771060	DIAG. CONDUCTA RATE BUN REAG. SET	Jul 21, 1977	Substantially Equivalent	J.T. Baker Chemical Co.
K761061	BLOOD-UREA-NITROGEN (BUN) ANALYZER 2	Jan 25, 1977	Substantially Equivalent	Beckman Instruments, Inc.
K760430	BUN-REATIVE	Nov 01, 1976	Substantially Equivalent	Boehringer Mannheim Corp.