Note: 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. |
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Device | ONCOR B/T GENE REARRANGEMENT TEST |
Generic Name | DNA-probe, b and t lymphocyte |
Regulation Number | 864.5220 |
Applicant | ONCOR, INC. 209 PERRY PKWY. GAITHERSBURG, MD 20877 |
PMA Number | P880016 |
Supplement Number | S002 |
Date Received | 04/10/1990 |
Decision Date | 04/24/1990 |
Product Code |
MAM |
Advisory Committee |
Hematology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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