Product Code: CDL FDA class 2 21 CFR 862.1770

Berthelot Indophenol, Urea Nitrogen

Clinical Chemistry

The Berthelot Indophenol Urea Nitrogen Test is a clinical chemistry device that measures blood urea nitrogen (BUN) concentrations using the Berthelot reaction, in which ammonia released from urea reacts with phenol and hypochlorite to form a blue indophenol dye detectable by colorimetry, used in the assessment of renal function. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CDL, 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: CDL
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 16 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K896845	RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT	Feb 16, 1990	Substantially Equivalent	Reagents Applications, Inc.
K893128	STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010	Jul 25, 1989	Substantially Equivalent	Stanbio Laboratory
K871651	COLORIMETRIC BUN REAGENT KIT	May 12, 1987	Substantially Equivalent	Biochemical Trade, Inc.
K864742	UREA NITROGEN(BUN), COLORIMETRIC METHOD	Jan 13, 1987	Substantially Equivalent	Tech-Co, Inc.
K863889	UREA NITROGEN TEST	Nov 24, 1986	Substantially Equivalent	U. S. Diagnostics, Inc.
K863076	UREAFAST	Sep 09, 1986	Substantially Equivalent	J. D. Assoc.
K860154	BUN (ENZYMATIC BERTHELOT) REAGENT SET	Feb 06, 1986	Substantially Equivalent	Sterling Diagnostics, Inc.
K831414	COLORIMETRIC BUN	Jun 16, 1983	Substantially Equivalent	Bio-Analytics Laboratories, Inc.
K822237	UREA NITROGEN REAGENT SET (MOD. BERTHEL	Aug 16, 1982	Substantially Equivalent	Sterling Biochemical, Inc.
K810261	EUROCHIMA UREA NITROGEN	Feb 10, 1981	Substantially Equivalent	Volu Sol Medical Industries
K801727	DATA-ZYME UREA NITROGEN, COLORIMETRIC	Sep 09, 1980	Substantially Equivalent	Data Medical Associates, Inc.
K800902	BUN-COLOR 2, BLOOD UREA NITROGEN TEST	Jun 09, 1980	Substantially Equivalent	Sclavo, Inc.
K792417	ELVI BLOOD UREA NITROGEN	Dec 07, 1979	Substantially Equivalent	Volu Sol Medical Industries
K781899	UREA NITROGEN TEST	Dec 20, 1978	Substantially Equivalent	Wako Intl., Inc.
K781306	UREA NITROGEN TEST KIT	Aug 31, 1978	Substantially Equivalent	Analytical & Research Chemicals, Inc.
K761152	S-UREA-N, IN VITRO DIAG FOR BUN	Dec 09, 1976	Substantially Equivalent	Advanced Biomedical Methods, Inc.