HER2 CISH PHARMDX KIT
FDA premarket approval P100024 · decided 2011-11-30
Approval details
- PMA number
- P100024
- 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
- 2010-06-21
- Decision date
- 2011-11-30
- Days to decision
- 527 days
- Decision code
- APWD
- Product code
- NYQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Glostrup
- Statement
- APPROVAL FOR THE HER2 CISH PHARMDX KIT. THIS DEVICE IS INDICATED TOR;HER2 CISH PHARMDX KIT IS INTENDED FOR DUAL-COLOR CHROMOGENIC VISUALIZATION OF SIGNALS ACHIEVED WITH DIRECTLY LABELED IN SITU HYBRIDIZATION PROBES TARGETING THE HER2 GENE AND CENTROMERIC REGION OF CHROMOSOME 17. THE KIT IS DESIGNED TO QUANTITATIVELY DETERMINE HER2 GENE STATUS IN FORMALIN-FIXED, PARAFFIN-EMBEDDED BREAST CANCER TISSUE SPECIMENS. RED AND BLUE CHROMOGENIC SIGNALS ARE GENERATED ON THE SAME TISSUE SECTION FOR EVALUATI
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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 |