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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameONCOR B/T GENE REARRANGEMENT TEST
Classification Namedna-probe, b and t lymphocyte
Generic Namegene rearrangement test
Regulation Number864.5220
ApplicantONCOR, INC.
PMA NumberP880016
Date Received03/01/1988
Decision Date10/10/1989
Product Code
MAM[ Registered Establishments with 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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