ONCOR B/T GENE REARRANGEMENT TEST
FDA premarket approval P880016/S001 · decided 1990-04-24
Approval details
- PMA number
- P880016
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ONCOR B/T GENE REARRANGEMENT TEST
- Generic name
- DNA-probe, b and t lymphocyte
- Applicant
- Oncor, Inc.
- Date received
- 1989-12-18
- Decision date
- 1990-04-24
- Days to decision
- 127 days
- Decision code
- APPR
- Product code
- MAM
- Advisory committee
- Hematology
- Expedited review
- No
- Location
- Suite 13, MD
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