PMA P930027S028

Device: IMMULITE® /IMMULITE® 1000 PSA, IMMULITE® 2000 PSA and IMMULITE® /IMMULITE® 1000 Third Generation PSA
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P930027
Supplement: S028
Product code: MTF
Decision date: 2022-10-14
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Approval order statement: Change in material composition of the glass bulb used in PMT (Photo Multiplier Tube) Assembly on the IMMULITE Family of Instruments.

Current openFDA PMA Record#

Device: IMMULITE® /IMMULITE® 1000 PSA, IMMULITE® 2000 PSA and IMMULITE® /IMMULITE® 1000 Third Generation PSA
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P930027
Supplement: S028
Product code: MTF
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Decision date: 2022-10-14
Decision code: OK30
Date received: 2022-09-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change in material composition of the glass bulb used in PMT (Photo Multiplier Tube) Assembly on the IMMULITE Family of Instruments.