Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: RIANEN 3H
• Generic Name: KIT, ASSAY, ESTROGEN RECEPTOR
• Regulation Number: 864.1860
• Applicant: Dupont Legal; 4417 Lancaster Pike; Wilmington, DE 19805
• PMA Number: P800061
• Supplement Number: S008
• Date Received: 01/22/1985
• Decision Date: 03/26/1985
• Withdrawal Date: 02/07/2012
• Product Code: LPJ
• Advisory Committee: Clinical Chemistry
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No