• 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 NameAIA-PACK PA PSA, ST AIA-PACK PA PSA
Classification Nameprostate-specific antigen (psa) for management of prostate cancers
Generic Nameimmunoassay, psa
Regulation Number866.6010
ApplicantTOSOH BIOSCIENCE, INC.
PMA NumberP910065
Supplement NumberS006
Date Received06/06/2005
Decision Date11/30/2005
Product Code
LTJ[ Registered Establishments with LTJ ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in the manufacturing process of the monoclonal antibodies used in the production of the assays and change in the manufacturing facility used for the above manufacturing process from nisseiken co. , ltd. , tokyo, japan to tosoh aia, inc. In toyama, japan.
-
-