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O-Phthalaldehyde, Urea Nitrogen

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
862.1770
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 862.1770 Urea nitrogen test system

§ 862.1770 Urea nitrogen test system.

(a) Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

(b) Classification. Class II.

O-Phthalaldehyde, Urea Nitrogen

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
862.1770
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 862.1770 Urea nitrogen test system

§ 862.1770 Urea nitrogen test system.

(a) Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

(b) Classification. Class II.