CDR · 1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine
Clinical Chemistry · 21 CFR 862.1730 · Class 1
Overview
| Product Code | CDR |
|---|---|
| Device Name | 1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine |
| Regulation | 21 CFR 862.1730 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A free tyrosine test system is a device intended to measure free tyrosine (an amono acid) in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of diseases such as congenital tyrosinemia (a disease that can cause liver/kidney disorders) and as an adjunct to the measurement of phenylalanine in detecting congenital phenylketonuria (a disease that can cause brain damage).
Classification Rationale
Class I.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K970093 | TYROSINE 50-HOUR REAGENT KIT | Astoria-Pacific, Inc. | Mar 19, 1998 | SESE |
Top Applicants
- Astoria-Pacific, Inc. — 1 clearance
