• 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 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.
 
DeviceACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Classification Namep2psa
Generic Namep2psa
Applicant
BECKMAN COULTER, INC.
1000 lake hazeltine dr.
chaska, MN 55318
PMA NumberP090026
Supplement NumberS006
Date Received03/29/2013
Decision Date06/07/2013
Product Code
OYA[ Registered Establishments with OYA ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of a sample probe used in the unicel dxi600, 800 and the unicel dxc 660i, 680i, 860i, and 880i.
-
-