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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceONCOR B/T GENE REARRANGEMENT TEST
Classification Namedna-probe, b and t lymphocyte
Generic Namedna-probe, b and t lymphocyte
Regulation Number864.5220
Applicant
ONCOR, INC.
209 perry pkwy.
gaithersburg, MD 20877
PMA NumberP880016
Supplement NumberS002
Date Received04/10/1990
Decision Date04/24/1990
Product Code
MAM
Advisory Committee Hematology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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