• 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 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 NameBIO-RAD CYCLOSPORINE BY HPLC TEST
Classification Namehigh performance liquid chromatography for cyclosporine
Generic Namehigh performance liquid chromatography cyclosporine
Regulation Number862.1235
ApplicantBIO-RAD
PMA NumberP880032
Date Received04/21/1988
Decision Date07/24/1989
Reclassified Date 10/16/2002
Product Code
MGS
Docket Number 89M-0321
Notice Date 08/22/1989
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 
-
-