Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: IMMULITE SYSTEMS PSA & THIRD GENERATION PSA REAGENTS
• Generic Name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
• Applicant: Siemens Healthcare Diagnostics, Inc.; Glyn Rhonwy, Llanberis; Gwynedd Ll55 4el LL554EL
• PMA Number: P930027
• Date Received: 08/10/1993
• Decision Date: 09/15/1995
• Product Code: MTF
• Docket Number: 96M-0217
• Notice Date: 09/12/1996
• Advisory Committee: Immunology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH Recalls

Approval Order Statement  
APPROVAL FOR THE COAT-A-COUNT PSA IRMA

• Approval Order: Approval Order
• Supplements: S001 S003 S004 S005 S006 S007 S008 S010 S011 S012 S013 ; S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 ; S026 S027 S028 S034 S035 S036 S037 S038 S039 S040 S041