PMA supplement
P110012 S009: VYSIS ALK BREAK APART FISH PROBE KIT,PROBECHEK ALK POSITIVE CONTROL SLIDES KIT,PROBECHEK ALK NEGATIVE CONTROL SLIDES KIT
FDA PMA supplement · Normal 180 Day Track · Abbott Molecular, Inc.
Key facts
| Original PMA | P110012 |
|---|---|
| Supplement number | S009 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | VYSIS ALK BREAK APART FISH PROBE KIT,PROBECHEK ALK POSITIVE CONTROL SLIDES KIT,PROBECHEK ALK NEGATIVE CONTROL SLIDES KIT |
| Generic name | Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement |
| Applicant | Abbott Molecular, Inc. |
| Product code | OWE |
| Received date | Oct 1, 2014 |
| Decision date | Jul 2, 2015 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: