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


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 Name1YCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS
Classification Nameradioimmunoassay for cyclosporine
Generic Namecyclosporine radioimmunoassay
Regulation Number862.1235
ApplicantINCSTAR CORP.
PMA NumberP890065
Supplement NumberS001
Date Received10/10/1990
Decision Date01/30/1991
Product Code
MGV[ Registered Establishments with MGV ]
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
-
-