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(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT
• Generic Name: KIT, ASSAY, PROGESTERONE RECEPTOR
• Regulation Number: 864.1860
• Applicant: Dupont Legal; 4417 Lancaster Pike; Wilmington, DE 19805
• PMA Number: P820052
• Supplement Number: S001
• Date Received: 11/29/1983
• Decision Date: 02/08/1984
• Withdrawal Date: 02/07/2012
• Product Code: LPI
• Advisory Committee: Clinical Chemistry
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No