Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
Trade NameRAPID FFN FOR THE TLI SYSTEM
Classification Nameenzyme immunoassay, fetal fibronectin
ApplicantADEZA BIOMEDICAL
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.
-
-