HER2 CISH PHARMDX KIT
FDA premarket approval P100024/S011 · decided 2017-03-24
Approval details
- PMA number
- P100024
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HER2 CISH PHARMDX KIT
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Applicant
- Dako Denmark A/S
- Date received
- 2016-12-27
- Decision date
- 2017-03-24
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- NYQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Glostrup
- Statement
- Approval for an update to DakoLink software version 4.2.
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 |
|---|---|---|
| FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) (K170028) | Dako Denmark A/S | 2017-12-21 |
| FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) (K170005) | Dako Denmark A/S | 2017-12-21 |