# K970093: Tyrosine 50-Hour Reagent Kit

- Pathway: 510(k) (Traditional)
- Applicant: Astoria-Pacific, Inc.
- Decided: Mar 19, 1998 after 433 days
- Product code: CDR (1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine)
- Device class: 1
- Regulation: 21 CFR 862.1730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Technicon Tyrosine test: named in the summary without a submission number

## Indications for use
This method is for the quantitative determination of the amino acid tyrosine in whole blood saturated filter paper disks using the API™ 300 SPOTCHECK® Analyzer or the RFA 300 System. Measurements obtained by this device are used primarily to screen newborns for congenital tyrosinemia, a disease that can cause liver/kidney disorders.

Source page: https://510kreport.com/device/K970093
Methodology: https://510kreport.com/methodology