• 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 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 NameACCESS HYBRITECH PSA REAGENTS ACCESS IMMUNOASSAY SYSTEMS
Classification Nameprostate-specific antigen (psa) for management of prostate cancers
Generic Namekit, test, prostate specific antigen
Regulation Number866.6010
ApplicantBECKMAN COULTER, INC.
PMA NumberP850048
Supplement NumberS019
Date Received12/20/2002
Decision Date03/03/2003
Product Code
LTJ[ Registered Establishments with LTJ ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add the access hybritech psa assay to the unicel dxi 800 access immunoassay system.
-
-