• 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 | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
Trade NameFETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)
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 
-
-