ONCOR B/T GENE REARRANGEMENT TEST
FDA premarket approval P880016/S003 · decided 1992-01-23
Approval details
- PMA number
- P880016
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ONCOR B/T GENE REARRANGEMENT TEST
- Generic name
- DNA-probe, b and t lymphocyte
- Applicant
- Oncor, Inc.
- Date received
- 1991-06-07
- Decision date
- 1992-01-23
- Days to decision
- 230 days
- Decision code
- APPR
- Product code
- MAM
- Advisory committee
- Hematology
- Expedited review
- No
- Location
- Suite 13, MD
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