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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
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
Date Received03/01/1988
Decision Date10/10/1989
Product Code
MAM
Docket Number 89M-0456
Notice Date 11/14/1989
Advisory Committee Hematology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 
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