PMA P930027S017

Device: IMMULITE/IMMULITE 1000 PSA, IMMULITE 2000 PSA
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P930027
Supplement: S017
Product code: MTF
Decision date: 2017-03-21
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Approval order statement: Approval for a change to quality control testing procedure to reduce the number of dilution levels of WHO 96/670 used in the value assignment of the PSA Release panel and remove requirement to value assign the Male normal panel against WHO 96/670.

Current openFDA PMA Record#

Device: IMMULITE/IMMULITE 1000 PSA, IMMULITE 2000 PSA
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P930027
Supplement: S017
Product code: MTF
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Decision date: 2017-03-21
Decision code: APPR
Date received: 2016-08-17
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a change to quality control testing procedure to reduce the number of dilution levels of WHO 96/670 used in the value assignment of the PSA Release panel and remove requirement to value assign the Male normal panel against WHO 96/670.