HER2 CISH PHARMDX KIT
FDA premarket approval P100024/S007 · decided 2015-09-10
Approval details
- PMA number
- P100024
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2015-08-13
- Decision date
- 2015-09-10
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NYQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Glostrup
- Statement
- ALTERNATE WAREHOUSE ESTABLISHED WITHIN THE CURRENT FACILITY. THE CHANGE IS BEING MADE FOR THE STORAGE OF FINISHED DEVICES AFTER THEY HAVE BEEN QA RELEASED.
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 |