PNK · Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)
· Class 3
Overview
| Product Code | PNK |
|---|---|
| Device Name | Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53) |
| Device Class | Class 3 |
| Review Panel |
Identification
A chromosome 17p deletion (TP53) fluorescence in situ hybridization (FISH) kit is a test to detect deletion of the TP53 gene in peripheral blood specimens from patients with B-cell chronic lymphocytic leukemia (CLL).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P150041 | VYSIS CLL FISH PROBE KIT | Abbott Molecular, Inc. | Apr 11, 2016 | APPR |
Top Applicants
- Abbott Molecular, Inc. — 1 clearance
