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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameenzyme immunoassay, fetal fibronectin
ApplicantHOLOGIC, INC.
PMA NumberP920048
Supplement NumberS008
Date Received06/27/2014
Decision Date07/24/2014
Product Code
LKV[ Registered Establishments with LKV ]
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to add an intermediate solution in the manufacturing process of positive reference calibrator, to modify the personnel in charge of in-process manufacturing testing and to increase the number of replicates in bulk solution concentration verification procedure for both positive reference calibrator and positive control. The positive reference calibrator and the positive control are components of the rapid ffn control kit for use with the tliiq analyzer and ffn elisa test.