• 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.
 
DeviceELECSYS FREE PSA CALCHECK
Classification Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Generic Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, IN 46250
PMA NumberP000027
Supplement NumberS008
Date Received05/27/2010
Decision Date06/08/2010
Product Code
MTG[ Registered Establishments with MTG ]
Advisory Committee Immunology
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in manufacturing site for final packaging and labeling of the device.
-
-