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 Drive; 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
• Recalls: CDRH Recalls
• Supplements: S001 S002 S003 S011 S008 S009 S005 S006 S015 S018 S014 ; S021 S023 S013 S016 S017 S022 S020 S019 S024 S025