This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | ONCOR B/T GENE REARRANGEMENT TEST |
| Classification Name | Dna-probe, B And T Lymphocyte |
| Generic Name | Dna-probe, B And T Lymphocyte |
| Applicant | ONCOR, INC. |
| Date Received | 1992-08-26 |
| Decision Date | 1993-01-13 |
| PMA | P880016 |
| Supplement | S004 |
| Product Code | MAM |
| Advisory Committee | Hematology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ONCOR, INC. 209 Perry Pkwy. gaithersburg, MD 20877 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P880016 | Original Filing | |
| S004 | 1992-08-26 | Normal 180 Day Track |
| S003 | 1991-06-07 | Normal 180 Day Track |
| S002 | 1990-04-10 | Normal 180 Day Track |
| S001 | 1989-12-18 | Normal 180 Day Track |