Premarket Approval (PMA)

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.

• Device: ABBOTT ER-EIA MONOCLONAL DIAG. KIT
• Generic Name: KIT, ASSAY, ESTROGEN RECEPTOR
• Regulation Number: 864.1860
• Applicant: Abbott Laboratories; 200 ABBOTT PARK RD.; ABBOTT PARK,, IL 60064-3537
• PMA Number: P850029
• Date Received: 05/17/1985
• Decision Date: 10/17/1988
• Withdrawal Date: 10/15/2003
• Product Code: LPJ
• Docket Number: 88M-0368
• Notice Date: 12/16/1988
• Advisory Committee: Clinical Chemistry
• Expedited Review Granted?: No
• Combination Product: No
• Supplements: S001 S002