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.
 
DeviceBIO-RAD CYCLOSPORINE BY HPLC TEST
Generic NameHIGH PERFORMANCE LIQUID CHROMATOGRAPHY FOR CYCLOSPORINE
Regulation Number862.1235
ApplicantBio-Rad
4000 ALFRED NOBEL DR.
HERCULES, CA 94547-1803
PMA NumberP880032
Supplement NumberS001
Date Received12/06/1990
Decision Date03/14/1991
Reclassified Date 10/16/2002
Product Code MGS 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
-
-