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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namedna-probe, b and t lymphocyte
Generic Namedna-probe, b and t lymphocyte
Regulation Number864.5220
ApplicantONCOR, INC.
PMA NumberP880016
Supplement NumberS003
Date Received06/07/1991
Decision Date01/23/1992
Product Code
MAM[ Registered Establishments with MAM ]
Advisory Committee Hematology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No