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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | 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 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.
 
DeviceEMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
Generic NameCYCLOSPORINE
Regulation Number862.1235
ApplicantDADE BEHRING, INC.
PO BOX 6101
NEWARK, DE 19714-6101
PMA NumberP920031
Supplement NumberS001
Date Received07/02/1999
Decision Date08/11/2000
Reclassified Date 10/16/2002
Product Code MKW 
Advisory Committee Toxicology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR EMIT(R) CYCLOSPORINE SAMPLE PRETREATMENT REAGENT AND COBAS INTEGRA 700 CYCLOSPORINE.
-
-