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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Nameenzyme immunoassay, fetal fibronectin
ApplicantHOLOGIC, INC.
PMA NumberP920048
Date Received10/20/1992
Decision Date09/21/1995
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
Recalls CDRH Recalls
Supplements: S001 S002 S003 S005 S006 S008 S009