BOND ORACLE HER2 IHC SYSTEM
FDA premarket approval P090015 · decided 2012-04-18
Approval details
- PMA number
- P090015
- Trade name
- BOND ORACLE HER2 IHC SYSTEM
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Applicant
- Leica Biosystems
- Date received
- 2009-07-22
- Decision date
- 2012-04-18
- Days to decision
- 1001 days
- Decision code
- APPR
- Product code
- MVC
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- APPROVAL FOR THE BOND ORACLE HER2 IHC SYSTEM. THIS DEVICE IS INDICATED FOR: BOND ORACLE HER2 IHC SYSTEM IS A SEMI-QUANTITATIVE IMMUNOHISTOCHEMICAL (IHC) ASSAY TO DETERMINE HER2 (HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2) ONCOPROTEIN STATUS IN FORMALIN-FIXED, PARRAFIN EMBEDDED BREAST CANCER TISSUE PROCESSED FOR HISTOLOGICAL EVALUATION FOLLOWING AUTOMATED STAINING ON THE BOND-MAX SLIDE STAINING INSTRUMENT. THE BOND ORACLE HER2 IHC SYSTEM IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM
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