Last synced on 2 December 2022 at 11:04 pm

Column Or Paper Chromatography Plus Ninhydrin, Phenylalanine

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
862.1555
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 862.1555 Phenylalanine test system

§ 862.1555 Phenylalanine test system.

(a) Identification. A phenylalanine test system is a device intended to measure free phenylalanine (an amino acid) in serum, plasma, and urine. Measurements of phenylalanine are used in the diagnosis and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation.

(b) Classification. Class II.

Column Or Paper Chromatography Plus Ninhydrin, Phenylalanine

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
862.1555
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 862.1555 Phenylalanine test system

§ 862.1555 Phenylalanine test system.

(a) Identification. A phenylalanine test system is a device intended to measure free phenylalanine (an amino acid) in serum, plasma, and urine. Measurements of phenylalanine are used in the diagnosis and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation.

(b) Classification. Class II.