Premarket Approval (PMA)

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.

• Trade Name: ABBOTT PGR-EIA MONOCLONAL
• Classification Name: kit, assay, progesterone receptor
• Generic Name: immunoassay for measurement of progesterone rece
• Regulation Number: 864.1860
• Applicant: ABBOTT LABORATORIES
• PMA Number: P900013
• Date Received: 02/16/1990
• Decision Date: 09/06/1990
• Withdrawal Date: 07/26/2004
• Product Code: LPI
• Docket Number: 90m-0299
• Notice Date: 10/23/1990
• Advisory Committee: Clinical Chemistry
• Expedited Review Granted?: No
• Combination Product: No
• Supplements: S001 S002