PMA
P150041: VYSIS CLL FISH PROBE KIT
FDA PMA · Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53) · Abbott Molecular, Inc.
Key facts
| PMA number | P150041 |
|---|---|
| Trade name | VYSIS CLL FISH PROBE KIT |
| Generic name | Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53) |
| Applicant | Abbott Molecular, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | PNK |
| Approval date | Apr 11, 2016 |
| Docket number | 16M-1167 |
| Notice date | May 11, 2016 |
| Establishment registration | 3005248192 |
| FEI number | 3005248192 |
At a glance
- 1–9 Supplements
- Feb 18, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: