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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceRAPID FFN FOR THE TLI SYSTEM
Generic NameENZYME IMMUNOASSAY, FETAL FIBRONECTIN
ApplicantHOLOGIC, INC.
1240 Elko Drive
Sunnyvale, CA 94089
PMA NumberP920048
Supplement NumberS003
Date Received09/11/2000
Decision Date03/09/2001
Product Code LKV 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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.
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