ONCOR B/T GENE REARRANGEMENT TEST
FDA premarket approval P880016 · decided 1989-10-10
Approval details
- PMA number
- P880016
- Trade name
- ONCOR B/T GENE REARRANGEMENT TEST
- Generic name
- DNA-probe, b and t lymphocyte
- Applicant
- Oncor, Inc.
- Date received
- 1988-03-01
- Decision date
- 1989-10-10
- Days to decision
- 588 days
- Decision code
- APPR
- Product code
- MAM
- Advisory committee
- Hematology
- Expedited review
- No
- Location
- Suite 13, MD
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.