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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
PMA NumberP920048
Supplement NumberS003
Date Received09/11/2000
Decision Date03/09/2001
Product Code
LKV[ Registered Establishments with LKV ]
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following: 1) a change in the calibration procedure that allows for extended calibration, accomplished with a software modification and no longer requireing the use of the ffn positive reference calibrator; and 2) the addition of a quality control component, the tli qc cassette, for the tli analyzer coupled with a decrease in frequency of testing liquid controls.