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: FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)
• Generic Name: ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
• Applicant: Hologic, Inc.; 1240 Elko Dr.; Sunnyvale, CA 94089
• PMA Number: P920048
• Date Received: 10/20/1992
• Decision Date: 09/21/1995
• Product Code: LKV
• Docket Number: 96M-0218
• Notice Date: 07/08/1996
• Advisory Committee: Toxicology
• Expedited Review Granted?: Yes
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH Recalls
• Supplements: S001 S006 S002 S003 S011 S008 S009 S005 S015 S021 S022 ; S024 S026 S027 S013 S014 S019 S016 S017 S018 S025 S023 S020 ; S028 S029