TRUQUANT(R) BR(TM) RIA
FDA premarket approval P950011 · decided 1996-03-29
Approval details
- PMA number
- P950011
- Trade name
- TRUQUANT(R) BR(TM) RIA
- Generic name
- ANTIGEN, CANCER 549
- Applicant
- Biomira, Inc.
- Date received
- 1995-02-28
- Decision date
- 1996-03-29
- Days to decision
- 395 days
- Decision code
- APPR
- Product code
- MJB
- Advisory committee
- Immunology
- Expedited review
- Yes
- Location
- Rexdale, Ontario
- Statement
- APPROVAL FOR AN IN VITRO DIAGNOSITC DEVICE (BIOMIRA TRUQUANT BR RIA)
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.