VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALK
FDA premarket approval P110012 · decided 2011-08-26
Approval details
- PMA number
- P110012
- Trade name
- VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALK
- Generic name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Applicant
- Abbott Molecular, Inc.
- Date received
- 2011-04-01
- Decision date
- 2011-08-26
- Days to decision
- 147 days
- Decision code
- APPR
- Product code
- OWE
- Advisory committee
- Pathology
- Expedited review
- Yes
- Location
- Des Plaines, IL
- Statement
- APPROVAL FOR THE VYSIS ALK BREAK APART FISH PROBE KIT; VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT; PROBECHEK ALK NEGATIVE CONTROL SLIDES; AND PROBECHEK ALK POSITIVE CONTROL SLIDES. THIS DEVICE IS INDICATED FOR: THE VYSIS ALK BREAK APART FISH PROBE KIT IS A QUALITATIVE TEST TO DETECT REARRANGEMENTS INVOLVING THE ALK GENE VIA FLUORESCENCE IN SITU HYBRIDIZATION (FISH) IN FORMALIN-FIXED PARAFFIN -EMBEDDED (FFPE) NON-SMALL CELL LUNG CANCER (NSCLC) TISSUE SPECIMENS TO AID IN I
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Alinity m HCV (K252102) | Abbott Molecular, Inc. | 2025-09-25 |
| Alinity m EBV (09N43-095) (K243489) | Abbott Molecular, Inc. | 2025-07-28 |
| Alinity m CMV (K243485) | Abbott Molecular, Inc. | 2025-07-01 |
| Alinity m BKV (K241921) | Abbott Molecular, Inc. | 2025-03-24 |
| Alinity m Resp-4-Plex (K241573) | Abbott Molecular, Inc. | 2025-02-14 |
| Alinity m HSV 1 & 2 / VZV (K233349) | Abbott Molecular, Inc. | 2024-05-03 |
| Alinity m STI Assay (K222379) | Abbott Molecular, Inc. | 2023-03-03 |
| Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) (K212778) | Abbott Molecular, Inc. | 2022-07-15 |