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: ADEZA FETAL FIBRONECTIN EIK
• Classification Name: enzyme immunoassay, fetal fibronectin
• Applicant: CYTYC PRENATAL PRODUCTS CORPORATION
• PMA Number: P920048
• Date Received: 10/20/1992
• Decision Date: 09/21/1995
• Product Code: LKV [ Registered Establishments with LKV ]
• Docket Number: 96M-0218
• Notice Date: 07/08/1996
• Advisory Committee: Clinical Chemistry
• Expedited Review Granted?: Yes
• Combination Product: No
• Supplements: S001 S002 S003 S005 S006