• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
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.
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