Premarket Approval (PMA)

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.

• Trade Name: ABBOTT IMX(R) PSA*
• Classification Name: prostate-specific antigen (psa) for management of prostate cancers
• Generic Name: abbolabo
• Regulation Number: 866.6010
• Applicant: ABBOTT LABORATORIES
• PMA Number: P910007
• Supplement Number: S001
• Date Received: 08/26/1992
• Decision Date: 09/13/1994
• Product Code: LTJ [ Registered Establishments with LTJ ]
• Advisory Committee: Immunology
• Supplement Type: normal 180 day track
• Supplement Reason: location change: manufacturer
• Expedited Review Granted?: No
• Combination Product: No